Page last updated: 2024-12-07

trospium chloride

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

trospium chloride : An organic chloride salt of trospium. It is an antispasmodic drug used for the treatment of overactive bladder. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5284631
CHEMBL ID3084748
CHEBI ID32270
SCHEMBL ID25785
SCHEMBL ID13836646
MeSH IDM0044367

Synonyms (92)

Synonym
AC-4235
keptan
einecs 233-875-4
spiro (8-azoniabicyclo(3.2.1)octane-8,1'-pyrrolidinium), 3-((hydroxydiphenylacetyl)oxy)-, chloride, (1alpha, 3beta, 5alpha)
santura
spasmex
sanctura
trospii chloridum [inn-latin]
spiro(1-alpha-h,5-alpha-h-nortropane-8,1'-pyrrolidinium), 3-alpha-hydroxy-, chloride, benzilate
8-alpha-benziloyloxy-6,10-ethano-5-azoniaspiro(4.5)decane chloride
azoniaspiro(3-alpha-benziloyloxy-nortropan-8,1'-pyrrolidine)-chloride
spiro(8-azoniabicyclo(3.2.1)octane-8,1'-pyrrolidinium, 3-((hydroxydiphenylacetyl)oxy)-, chloride, (1alpha,3beta,5alpha)-
spasmo 3
relaspium
spasmo-lyt
chlorure de trospium [inn-french]
cloruro de trospio [inn-spanish]
as xvii
3alpha-hydroxyspiro(1alphah,5alphah-nortropane-8,1'-pyrrolidinium) chloride benzilate
azoniaspiro compound xvii
AKOS015833209
trospium chloride
10405-02-4
NCGC00167438-01
trosec
A800884
2-hydroxy-2,2-diphenylacetic acid [(1s,5r)-3-spiro[8-azoniabicyclo[3.2.1]octane-8,1'-azolidin-1-ium]yl] ester chloride
[(1s,5r)-spiro[8-azoniabicyclo[3.2.1]octane-8,1'-azolidin-1-ium]-3-yl] 2-oxidanyl-2,2-diphenyl-ethanoate chloride
uraplex
cas-10405-02-4
dtxcid903724
tox21_112442
spasmoplex
sanctura xr
unii-1e6682427e
ip631
cloruro de trospio
chlorure de trospium
1e6682427e ,
trospium chloride [usan:usp:inn:ban:jan]
trospii chloridum
trospium cl
BCP0726000291
trospium chloride (sanctura)
CHEMBL3084748
S2549
trospium chloride [orange book]
trospium chloride [who-dd]
regurin
trospium chloride [usan]
trospium chloride [mart.]
trospium chloride [mi]
trospium chloride [usp monograph]
trospium chloride [jan]
trospium chloride [usp-rs]
ip-631
spiro(8-azoniabicyclo(3.2.1)octane-8,1'-pyrrolidinium), 3-((hydroxydiphenylacetyl)oxy)-, chloride, (1.alpha., 3.beta., 5.alpha.)
3.alpha.-hydroxy-spiro(1.alpha.h,5.alpha.h-nortropane-8,1'-pyrrolidinium) chloride benzilate
trospium chloride [inn]
trospium chloride [ep monograph]
HY-B0461
trospium (chloride)
T3305
SCHEMBL25785
tox21_112442_1
NCGC00167438-02
flotros
SCHEMBL13836646
W-108827
(1s,3r,5r)-3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-8lambda(5)-azaspiro[bicyclo[3.2.1]octane-8,1'-pyrrolidin]-8-ylium chloride
spasmed
trospikan
trofame
CHEBI:32270 ,
HMS3656C16
RVCSYOQWLPPAOA-QKYUOBHYSA-M
I11574
trospiumchlorid
SW219146-1
mfcd00865254
rel-(1r,3r,5s)-3-(2-hydroxy-2,2-diphenylacetoxy)spiro[bicyclo[3.2.1]octane-8,1'-pyrrolidin]-1'-ium chloride
BCP23426
HMS3884H08
CCG-268976
Q27252312
rel-(1r,3r,5s)-3-(2-hydroxy-2,2-diphenylacetoxy)spiro[bicyclo[3.2.1]octane-8,1'-pyrrolidin]-1'-iumchloride
regurin xl
bdbm50540489
(1s,3s,5r)-3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-8lambda5-azaspiro[bicyclo[3.2.1]octane-8,1'-pyrrolidin]-8-ylium chloride
EN300-6497322
Z1980444595
PD052468

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Safety was evaluated on the basis of adverse events (AEs), vital signs and laboratory tests."( Trospium chloride in patients with detrusor overactivity: meta-analysis of placebo-controlled, randomized, double-blind, multi-center clinical trials on the efficacy and safety of 20 mg trospium chloride twice daily.
Bulitta, M; Fröhlich, G; Strösser, W, 2002
)
0.31
"Trospium chloride (20 mg twice daily) is an effective and safe medication for the treatment of detrusor overactivity."( Trospium chloride in patients with detrusor overactivity: meta-analysis of placebo-controlled, randomized, double-blind, multi-center clinical trials on the efficacy and safety of 20 mg trospium chloride twice daily.
Bulitta, M; Fröhlich, G; Strösser, W, 2002
)
0.31
"3%) receiving placebo experienced ≥1 treatment-emergent adverse event considered at least possibly related to the study medication."( Safety and efficacy of once-daily trospium chloride extended-release in male patients with overactive bladder.
Ellsworth, PI; Ginsberg, DA; MacDiarmid, SA; Oefelein, MG; Sussman, DO, 2011
)
0.37
"Trospium XR is safe and effective in men with OAB."( Safety and efficacy of once-daily trospium chloride extended-release in male patients with overactive bladder.
Ellsworth, PI; Ginsberg, DA; MacDiarmid, SA; Oefelein, MG; Sussman, DO, 2011
)
0.37

Pharmacokinetics

Trospium chloride displays dose proportional increases in AUC and Cmax after a single dose within the clinically relevant dose range (20-60 mg) The only demographic characteristic associated with trospium. chloride pharmacokinetics was BSA.

ExcerptReferenceRelevance
" Trospium chloride displays dose proportional increases in AUC and Cmax after a single dose within the clinically relevant dose range (20-60 mg)."( Clinical pharmacokinetics of trospium chloride.
Doroshyenko, O; Fuhr, U; Jetter, A; Odenthal, KP, 2005
)
0.33
"5 hours) and half-life is longer (35."( Pharmacokinetics of once-daily trospium chloride 60 mg extended release and twice-daily trospium chloride 20 mg in healthy adults.
Harnett, M; Sabounjian, L; Sandage, B; Schwiderski, U; Shipley, J; Silver, N, 2010
)
0.36
" The developed assay method was applied to an oral pharmacokinetic study in humans."( Determination of the quaternary ammonium compound trospium in human plasma by LC-MS/MS: application to a pharmacokinetic study.
Bharathi, DV; Chatki, PK; Hotha, KK; Jayaveera, KN; Kumar, SS; Ravindranath, LK; Reddy, YN, 2010
)
0.36
"96) h; Tmax was (4."( Pharmacokinetic and bioequivalence studies of trospium chloride after a single-dose administration in healthy Chinese volunteers.
Gao, H; Guo, R; Li, R; Liu, X; Wang, B; Wei, C; Yuan, G; Zhang, R, 2012
)
0.38
" Plasma trospium chloride concentration data were pooled and a population pharmacokinetic model was derived using non-linear mixed-effects modelling."( Study of the population pharmacokinetic characteristics of once-daily trospium chloride 60 mg extended-release capsules in patients with overactive bladder and in healthy subjects.
Harnett, MD; MacLean, L; Sandage, BW; Schwiderski, U; Shipley, J, 2013
)
0.39
"The best population pharmacokinetic model was determined to be a two-compartment model with zero-order release into the depot compartment and first-order absorption."( Study of the population pharmacokinetic characteristics of once-daily trospium chloride 60 mg extended-release capsules in patients with overactive bladder and in healthy subjects.
Harnett, MD; MacLean, L; Sandage, BW; Schwiderski, U; Shipley, J, 2013
)
0.39
"This population pharmacokinetic analysis demonstrated that the only demographic characteristic associated with trospium chloride pharmacokinetics was BSA."( Study of the population pharmacokinetic characteristics of once-daily trospium chloride 60 mg extended-release capsules in patients with overactive bladder and in healthy subjects.
Harnett, MD; MacLean, L; Sandage, BW; Schwiderski, U; Shipley, J, 2013
)
0.39
" To evaluate potential transport mechanisms for TC, we measured affinity of the drug to the human uptake and efflux transporters known to be of pharmacokinetic relevance."( Expression of drug transporters and drug metabolizing enzymes in the bladder urothelium in man and affinity of the bladder spasmolytic trospium chloride to transporters likely involved in its pharmacokinetics.
Bexten, M; Graf, T; Grube, M; Jia, J; Keiser, M; Oswald, S; Rodewald, K; Schwantes, U; Siegmund, W; Zimmermann, U; Zolk, O, 2015
)
0.42
" Pharmacokinetics of trospium was evaluated using gas chromatography-mass spectrometry, noncompartmental evaluation, and pharmacokinetic modeling."( Effects of the P-Glycoprotein Inhibitor Clarithromycin on the Pharmacokinetics of Intravenous and Oral Trospium Chloride: A 4-Way Crossover Drug-Drug Interaction Study in Healthy Subjects.
Abebe, BT; Modess, C; Neumeister, C; Roustom, T; Scheuch, E; Schulz, HU; Schwantes, U; Siegmund, W; Tadken, T; Wegner, D; Weiss, M, 2019
)
0.51
" Furthermore, a drug interaction study with trospium chloride after intravenous (2 mg) and oral dosing (30 mg) plus ranitidine (300 mg) was performed in 12 healthy subjects and evaluated by noncompartmental analysis and population pharmacokinetic modeling."( Pharmacokinetic Drug-Drug Interactions Between Trospium Chloride and Ranitidine Substrates of Organic Cation Transporters in Healthy Human Subjects.
Abebe, BT; Meyer, MJ; Modess, C; Neumeister, C; Scheuch, E; Schulz, HU; Schwantes, U; Siegmund, W; Tadken, T; Tzvetkov, M; Wegner, D; Weiss, M, 2020
)
0.56
" The use of physiologically based pharmacokinetic models has gained importance and is nowadays a standard tool for food effect predictions at preclinical and clinical stages in the pharmaceutical industry."( Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug-Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models.
Emami Riedmaier, A; Kesisoglou, F; Parrott, N; Pepin, XJH; Wagner, C, 2021
)
0.62

Compound-Compound Interactions

ExcerptReferenceRelevance
"The authors studied a potential drug-drug interaction via findings from in vitro and in vivo studies, to assess whether the in vitro system was predictive of in vivo clinical pharmacokinetic outcomes."( Predictive power of an in vitro system to assess drug interactions of an antimuscarinic medication: a comparison of in vitro and in vivo drug-drug interaction studies of trospium chloride with digoxin.
Fox, L; Harnett, M; Lasseter, K; Profy, A; Sabounjian, L; Sandage, B; Shipley, J, 2006
)
0.33
" Because older individuals typically take multiple medications, clinicians must pay special attention to potential drug-drug interactions that may cause adverse events or alter drug efficacy."( Treatment of overactive bladder: selective use of anticholinergic agents with low drug-drug interaction potential.
Chancellor, MB; de Miguel, F, 2007
)
0.34
" In contrast to Spasmex, Mirabegron and Quercetin in combination with Testosterone and Estradiol contributed to stabilization of eNOS and nNOs expression already at early observation phases, and reduced the level of iNOS expression with its further disappearance in the later observation period."( MORPHOLOGICAL ASSESSMENT OF NO-SYNTHASE DISTRIBUTION IN OVERACTIVE BLADDER AND STRESS URINE INCONTINENCE IN ANIMAL MODELS ADMINISTERED WITH EXPERIMENTAL PHARMACOCORRECTION REGIMENS.
Iatsyna, O; Kostyev, F; Vernygorodskyi, S, 2018
)
0.48

Bioavailability

Trospium chloride is a muscarinic receptor blocker. It is poorly absorbed with different rates from areas in the jejunum and the cecum/ascending colon.

ExcerptReferenceRelevance
" Using this method it was possible to obtain pharmacokinetic data from plasma levels and urinary excretion, and to determine the bioavailability in man."( Determination of the bioavailability of the quaternary compound trospium chloride in man from urinary excretion data.
Mutschler, E; Schladitz-Keil, G; Spahn, H, 1986
)
0.27
" Comparing the area under the curves made it possible to estimate the bioavailability of the compound."( [Pupillometry: a non-invasive pharmacokinetic and pharmacodynamic method to study the action of trospium chloride (Spasmo-lyt) on smooth muscle].
Albrecht, H; Bruhn, R; Lorenz, D; Lücker, PW; Schumacher, M, 1983
)
0.27
" Improvements in drug delivery systems have altered drug bioavailability and pharmacokinetics."( Advancements in pharmacologic management of the overactive bladder.
Appell, RA; Dmochowski, RR, 2000
)
0.31
" The mean bioavailability is approximately 10% and decreases by concomitant food intake (to a mean of 26% of the fasting area under the plasma concentration-time curve [AUC])."( Clinical pharmacokinetics of trospium chloride.
Doroshyenko, O; Fuhr, U; Jetter, A; Odenthal, KP, 2005
)
0.33
"TCl, a quaternary amine, exhibits high solubility in water but low oral bioavailability (9."( Trospium chloride for the treatment of overactive bladder with urge incontinence.
Machado, C; Singh-Franco, D; Tuteja, S; Zapantis, A, 2005
)
0.33
"The objective of this study is to characterize the steady-state pharmacokinetics and compare the relative bioavailability of the extended-release capsule formulation of the antimuscarinic trospium chloride, developed for once-daily administration, and trospium chloride immediate-release tablets."( Pharmacokinetics of once-daily trospium chloride 60 mg extended release and twice-daily trospium chloride 20 mg in healthy adults.
Harnett, M; Sabounjian, L; Sandage, B; Schwiderski, U; Shipley, J; Silver, N, 2010
)
0.36
" a decrease in bioavailability upon the co-administration of compounds together with food, has been attributed particularly with high solubility/low permeability compounds (BCS class III)."( Mechanistic investigation of food effect on disintegration and dissolution of BCS class III compound solid formulations: the importance of viscosity.
Amidon, GL; Langguth, P; Radwan, A, 2012
)
0.38
"In the current study the involvement of ion pair formation between bile salts and trospium chloride (TC), a positively charged Biopharmaceutical Classification System (BCS) class III substance, showing a decrease in bioavailability upon coadministration with food (negative food effect) was investigated."( Ion pairing with bile salts modulates intestinal permeability and contributes to food-drug interaction of BCS class III compound trospium chloride.
Amidon, GL; Heinen, CA; Langguth, P; Reuss, S, 2013
)
0.39
" The bioavailability enhancing effect thus was most likely due to an interaction of the polyelectrolyte-drug complex with the mucus, which provided an intimate contact between the drug and the absorbing surface."( Mechanistic basis for unexpected bioavailability enhancement of polyelectrolyte complexes incorporating BCS class III drugs and carrageenans.
Heinen, C; Langguth, P; Reuss, S; Saaler-Reinhardt, S, 2013
)
0.39
" Furthermore, in silico modelling provided a plausible explanation of the pronounced reduction in the oral bioavailability of trospium when administered with food."( Improvement of trospium-specific absorption models for fasted and fed states in humans.
Cvijić, S; Langguth, P, 2014
)
0.4
"Food induced viscosity in the gastrointestinal tract is reported to reduce the bioavailability of tablets containing BCS class 3 drugs, mainly by retarding their disintegration and dissolution of the active pharmaceutical ingredient."( Designing robust immediate release tablet formulations avoiding food effects for BCS class 3 drugs.
Langguth, P; Zaheer, K, 2019
)
0.51
"The quaternary ammonium compound trospium chloride is poorly absorbed from 2 "absorption windows" in the jejunum and cecum/ascending colon, respectively."( Effects of the P-Glycoprotein Inhibitor Clarithromycin on the Pharmacokinetics of Intravenous and Oral Trospium Chloride: A 4-Way Crossover Drug-Drug Interaction Study in Healthy Subjects.
Abebe, BT; Modess, C; Neumeister, C; Roustom, T; Scheuch, E; Schulz, HU; Schwantes, U; Siegmund, W; Tadken, T; Wegner, D; Weiss, M, 2019
)
0.51
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
"Trospium chloride, a muscarinic receptor blocker, is poorly absorbed with different rates from areas in the jejunum and the cecum/ascending colon."( Pharmacokinetic Drug-Drug Interactions Between Trospium Chloride and Ranitidine Substrates of Organic Cation Transporters in Healthy Human Subjects.
Abebe, BT; Meyer, MJ; Modess, C; Neumeister, C; Scheuch, E; Schulz, HU; Schwantes, U; Siegmund, W; Tadken, T; Tzvetkov, M; Wegner, D; Weiss, M, 2020
)
0.56

Dosage Studied

No dosage adjustment is necessary for metformin when coadministered with trospium chloride XR. A drug interaction study with troSpium chloride after intravenous (2 mg) and oral dosing (30 mg) plus ranitidine was performed in 12 healthy subjects.

ExcerptRelevanceReference
"We assessed the efficacy and most appropriate dosage of trospium chloride (TCl) for managing bladder instability in children as compared with a placebo."( Trospium chloride for the treatment of detrusor instability in children.
Anguera, A; Caffarati, J; Estornell, F; Lopez Pereira, P; Miguelez, C, 2003
)
0.32
" While trospium chloride dosage adjustments based on age or sex appear unwarranted, such adjustments may be needed in patients with severe renal impairment."( Trospium chloride in the management of overactive bladder.
Rovner, ES, 2004
)
0.32
"The dosage of the antimuscarinic drugs: Tolterodine ER or Trospium was increased to a higher-than-recommended dosage in patients where the manufacturer's recommended dosage had failed."( Neurogenic bladder treatment by doubling the recommended antimuscarinic dosage.
Aguilar, Y; Horstmann, M; Schaefer, T; Sievert, KD; Stenzl, A, 2006
)
0.33
" If neurogenic detrusor overactivity continued and the medication was well tolerated, the dosage was doubled to either 8 mg of Tolterodine ER [2 x 4 mg (n = 11)] or 90 mg of Trospium [3 x 30 mg (n = 10)]."( Neurogenic bladder treatment by doubling the recommended antimuscarinic dosage.
Aguilar, Y; Horstmann, M; Schaefer, T; Sievert, KD; Stenzl, A, 2006
)
0.33
"The increased dosage of Tolterodine or Trospium is an effective treatment in patients with neurogenic bladder."( Neurogenic bladder treatment by doubling the recommended antimuscarinic dosage.
Aguilar, Y; Horstmann, M; Schaefer, T; Sievert, KD; Stenzl, A, 2006
)
0.33
"To determine whether dose titration based on therapeutic response is superior to standard dosing of oral trospium chloride in patients with neurogenic detrusor overactivity and, moreover, to investigate the possible underlying causes of differences in efficacy at equal doses in some patients."( Trospium chloride in patients with neurogenic detrusor overactivity: is dose titration of benefit to the patients?
Bödeker, RH; Del Popolo, G; Di Benedetto, P; Haselmann, J; Madersbacher, H; Menarini, M; Schwantes, U, 2006
)
0.33
" Because the prevalence of OAB is greatest among the elderly, safety considerations regarding renal function must be noted, with dosage adjustment required in patients with severe renal impairment."( Trospium chloride treatment of overactive bladder.
Biastre, K; Burnakis, T, 2009
)
0.35
" With multiple dosing of trospium 60 mg extended-release once daily versus 20 mg twice daily, lower geometric least squares mean area under the concentration-time curve from 0 to 24 hours (17 360 vs 28 590 pg."( Pharmacokinetics of once-daily trospium chloride 60 mg extended release and twice-daily trospium chloride 20 mg in healthy adults.
Harnett, M; Sabounjian, L; Sandage, B; Schwiderski, U; Shipley, J; Silver, N, 2010
)
0.36
"Flexible dosing of anticholinergics used for overactive bladder (OAB) treatment is a useful strategy in clinical practice for achieving a maximum effective and maximum tolerated level of therapeutic benefit."( Dose escalation improves therapeutic outcome: post hoc analysis of data from a 12-week, multicentre, double-blind, parallel-group trial of trospium chloride in patients with urinary urge incontinence.
Bödeker, RH; Madersbacher, H; Neumeister, C; Zellner, M, 2010
)
0.36
"Flexible dosing of trospium was proven to be as effective, but better tolerated as the officially approved adjusted dose of oxybutynin."( Dose escalation improves therapeutic outcome: post hoc analysis of data from a 12-week, multicentre, double-blind, parallel-group trial of trospium chloride in patients with urinary urge incontinence.
Bödeker, RH; Madersbacher, H; Neumeister, C; Zellner, M, 2010
)
0.36
" These mechanisms refer primarily to the compound and not to the dosage form."( Mechanistic investigation of food effect on disintegration and dissolution of BCS class III compound solid formulations: the importance of viscosity.
Amidon, GL; Langguth, P; Radwan, A, 2012
)
0.38
"No dosage adjustment is necessary for metformin when coadministered with trospium chloride XR."( Effect of concomitant administration of trospium chloride extended release on the steady-state pharmacokinetics of metformin in healthy adults.
Bhasi, K; Kerr, S; Oefelein, MG; Patel, RK; Tong, W; Yu, D, 2013
)
0.39
" In addition, small dosage forms with a size of only a few millimetres were realised."( Lipid-based intravesical drug delivery systems with controlled release of trospium chloride for the urinary bladder.
Breitkreutz, J; Haupt, M; Heidenreich, A; Thommes, M, 2013
)
0.39
" They include viscosity of the media, precipitation of food constituents on the surface of the tablet and reduction of water diffusivity in the media as well as changes in the hydrodynamics in the surrounding media of the solid dosage form."( Bio-predictive tablet disintegration: effect of water diffusivity, fluid flow, food composition and test conditions.
Amidon, GL; Langguth, P; Radwan, A; Wagner, M, 2014
)
0.4
" This study reported the results of treatment with a high dosage of a single drug in children with refractory detrusor overactivity (DO)."( Combined low-dose antimuscarinics for refractory detrusor overactivity in children.
Fahmy, A; Mahfouz, W; Mokhless, I; Rhashad, H; Youssif, M, 2016
)
0.43
" They had persistent urgency and urgency urinary incontinence (UUI), even with behavioral bowel therapy, and used an optimized dosage of oxybutynine."( Combined low-dose antimuscarinics for refractory detrusor overactivity in children.
Fahmy, A; Mahfouz, W; Mokhless, I; Rhashad, H; Youssif, M, 2016
)
0.43
" Dosage regimen, duration of treatment, adverse events, withdrawals, and ease of subdivision of the prescribed SNAP-TAB tablet were documented."( Anticholinergic burden and comorbidities in patients attending treatment with trospium chloride for overactive bladder in a real-life setting: results of a prospective non-interventional study.
Bödeker, RH; Ivchenko, A; Neumeister, C; Wiedemann, A, 2018
)
0.48
" An influence of the dosage scheme (1 × 45 mg TC/d vs 3 × 15 mg TC/d) on clinical outcome could not be observed."( Anticholinergic burden and comorbidities in patients attending treatment with trospium chloride for overactive bladder in a real-life setting: results of a prospective non-interventional study.
Bödeker, RH; Ivchenko, A; Neumeister, C; Wiedemann, A, 2018
)
0.48
" The acceptance of the SNAP-TAB tablet, which facilitates flexible dosing with TC, was high, which is supportive in ensuring adherence in therapy."( Anticholinergic burden and comorbidities in patients attending treatment with trospium chloride for overactive bladder in a real-life setting: results of a prospective non-interventional study.
Bödeker, RH; Ivchenko, A; Neumeister, C; Wiedemann, A, 2018
)
0.48
" Furthermore, a drug interaction study with trospium chloride after intravenous (2 mg) and oral dosing (30 mg) plus ranitidine (300 mg) was performed in 12 healthy subjects and evaluated by noncompartmental analysis and population pharmacokinetic modeling."( Pharmacokinetic Drug-Drug Interactions Between Trospium Chloride and Ranitidine Substrates of Organic Cation Transporters in Healthy Human Subjects.
Abebe, BT; Meyer, MJ; Modess, C; Neumeister, C; Scheuch, E; Schulz, HU; Schwantes, U; Siegmund, W; Tadken, T; Tzvetkov, M; Wegner, D; Weiss, M, 2020
)
0.56
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (9)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
RAR-related orphan receptor gammaMus musculus (house mouse)Potency13.33320.006038.004119,952.5996AID1159521
AR proteinHomo sapiens (human)Potency22.08690.000221.22318,912.5098AID1259243; AID743035
estrogen nuclear receptor alphaHomo sapiens (human)Potency10.67170.000229.305416,493.5996AID743075
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency30.10650.057821.109761.2679AID1159526
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Muscarinic acetylcholine receptor M2Homo sapiens (human)Ki0.00110.00000.690210.0000AID1654798
Muscarinic acetylcholine receptor M4Homo sapiens (human)Ki0.00140.00000.79519.1201AID1654800
Muscarinic acetylcholine receptor M5Homo sapiens (human)Ki0.00600.00000.72926.9183AID1654801
Muscarinic acetylcholine receptor M1Homo sapiens (human)Ki0.00350.00000.59729.1201AID1654797
Muscarinic acetylcholine receptor M3Homo sapiens (human)Ki0.00100.00000.54057.7600AID1654799
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (39)

Processvia Protein(s)Taxonomy
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of heart contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
response to virusMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M2Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M4Homo sapiens (human)
cell surface receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M4Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M4Homo sapiens (human)
gastric acid secretionMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
dopamine transportMuscarinic acetylcholine receptor M5Homo sapiens (human)
transmission of nerve impulseMuscarinic acetylcholine receptor M5Homo sapiens (human)
regulation of phosphatidylinositol dephosphorylationMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M5Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M5Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M5Homo sapiens (human)
positive regulation of monoatomic ion transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
neuromuscular synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M1Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M1Homo sapiens (human)
cognitionMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of postsynaptic membrane potentialMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of glial cell proliferationMuscarinic acetylcholine receptor M1Homo sapiens (human)
positive regulation of intracellular protein transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M1Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
calcium-mediated signalingMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of monoatomic ion transmembrane transporter activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
synaptic transmission, cholinergicMuscarinic acetylcholine receptor M3Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of insulin secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein modification processMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ion channel modulating, G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ligand-gated ion channel signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M3Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (7)

Processvia Protein(s)Taxonomy
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
arrestin family protein bindingMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M4Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M4Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M5Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
signaling receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (18)

Processvia Protein(s)Taxonomy
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
clathrin-coated endocytic vesicle membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
asymmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
symmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
neuronal cell bodyMuscarinic acetylcholine receptor M2Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M2Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M4Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M4Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M4Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M5Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M5Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M5Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M1Homo sapiens (human)
Schaffer collateral - CA1 synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic density membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
endoplasmic reticulum membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basal plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basolateral plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (25)

Assay IDTitleYearJournalArticle
AID1654806Selectivity index, ratio of Ki for displacement of [3H]NMS from human recombinant muscarinic receptor M2 expressed in CHO-K1 cell membranes to Ki for displacement of [3H]NMS from human recombinant muscarinic receptor M3 expressed in CHO-K1 cell membranes
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1654801Displacement of [3H]NMS from human recombinant muscarinic receptor M5 expressed in CHO-K1 cell membranes incubated for 2 hrs by scintillation counting method
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1654799Displacement of [3H]NMS from human recombinant muscarinic receptor M3 expressed in CHO-K1 cell membranes incubated for 2 hrs by scintillation counting method
AID1654797Displacement of [3H]NMS from human recombinant muscarinic receptor M1 expressed in CHO-K1 cell membranes incubated for 2 hrs by scintillation counting method
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1654798Displacement of [3H]NMS from human recombinant muscarinic receptor M2 expressed in CHO-K1 cell membranes incubated for 2 hrs by scintillation counting method
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1654800Displacement of [3H]NMS from human recombinant muscarinic receptor M4 expressed in CHO-K1 cell membranes incubated for 2 hrs by scintillation counting method
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (164)

TimeframeStudies, This Drug (%)All Drugs %
pre-199010 (6.10)18.7374
1990's18 (10.98)18.2507
2000's56 (34.15)29.6817
2010's66 (40.24)24.3611
2020's14 (8.54)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials76 (41.53%)5.53%
Reviews29 (15.85%)6.00%
Case Studies1 (0.55%)4.05%
Observational2 (1.09%)0.25%
Other75 (40.98%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (24)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia [NCT03697252]Phase 2182 participants (Actual)Interventional2018-09-18Completed
An Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Subjects With DSM-5 Schizophrenia [NCT04659174]Phase 3156 participants (Actual)Interventional2021-02-01Completed
Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study [NCT05880862]Early Phase 148 participants (Anticipated)Interventional2023-09-28Recruiting
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia [NCT04659161]Phase 3252 participants (Actual)Interventional2020-12-16Completed
A Multi-center, Open-label Study to Assess the Effectiveness, Long-term Safety, Tolerability, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia [NCT05643170]Phase 34 participants (Actual)Interventional2022-11-08Terminated(stopped due to Company's business decision.)
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia [NCT04738123]Phase 3256 participants (Actual)Interventional2021-04-06Completed
A Phase I, Double-Blind, Randomized, Multiple-Dose, Pilot Study Comparing Xanomeline Administered Alone to Xanomeline Administered in Combination With Trospium Chloride in Normal Healthy Volunteers [NCT02831231]Phase 170 participants (Actual)Interventional2016-09-07Completed
Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence [NCT04227184]Phase 4220 participants (Anticipated)Interventional2020-02-13Recruiting
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial [NCT03709992]200 participants (Anticipated)Interventional2020-12-18Suspended(stopped due to Because of COVID-19 Crisis)
An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia [NCT05304767]Phase 3280 participants (Anticipated)Interventional2022-03-07Enrolling by invitation
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia [NCT05145413]Phase 3400 participants (Anticipated)Interventional2021-11-12Recruiting
Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence [NCT01166438]Phase 3249 participants (Actual)Interventional2010-03-31Completed
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in De Novo Subjects With DSM-5 Schizophrenia [NCT04820309]Phase 3568 participants (Actual)Interventional2021-06-02Active, not recruiting
A Phase 3, Multicenter, Two-part Study With a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) Followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese [NCT05919823]Phase 3158 participants (Anticipated)Interventional2023-05-29Recruiting
[NCT00932022]Phase 4127 participants (Actual)Interventional2009-07-31Completed
The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial [NCT01922115]Phase 459 participants (Actual)Interventional2013-06-30Completed
[NCT00863551]Phase 412 participants (Actual)Interventional2009-04-30Completed
Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease [NCT00465959]Phase 1/Phase 224 participants (Actual)Interventional2007-04-30Completed
Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects [NCT00986401]Phase 144 participants (Actual)Interventional2009-10-31Completed
[NCT01089751]Phase 4322 participants (Actual)Interventional2010-03-31Completed
[NCT01178827]Phase 420 participants (Actual)Interventional2010-08-31Completed
Pharmacokinetic Interaction Between Trospium Chloride After Intravenous (2 mg) and Oral Administration (30 mg) With Ranitidine (300 mg p.o.) as an Inhibitor of OCT1 and With Clarithromycin (500 mg p.o.) as an Inhibitor of P-glycoprotein in 24 Healthy Subj [NCT03011463]Phase 124 participants (Actual)Interventional2016-11-30Completed
A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Subjects With Idiopathic Overactive Bladder (iOAB) and Urinary Incontinence [NCT03109379]Phase 143 participants (Actual)Interventional2017-04-04Completed
A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Spinal Cord Injury Subjects With Neurogenic Detrusor Overactivity (NDO) [NCT03168828]Phase 17 participants (Actual)Interventional2017-04-24Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00863551 (5) [back to overview]Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose
NCT00863551 (5) [back to overview]Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
NCT00863551 (5) [back to overview]Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose
NCT00863551 (5) [back to overview]Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose
NCT00863551 (5) [back to overview]Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose
NCT00932022 (1) [back to overview]Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
NCT00986401 (2) [back to overview]Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®
NCT00986401 (2) [back to overview]Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®
NCT01089751 (8) [back to overview]Change From Baseline in Voided Volume
NCT01089751 (8) [back to overview]Change From Baseline in Urgency-Related Toilet Voids
NCT01089751 (8) [back to overview]Change From Baseline in Urgency Urinary Incontinence (UUI)
NCT01089751 (8) [back to overview]Change From Baseline in Urgency Severity
NCT01089751 (8) [back to overview]Change From Baseline in Nocturic Toilet Voids
NCT01089751 (8) [back to overview]Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)
NCT01089751 (8) [back to overview]Change From Baseline in Continent Days Per Week (CDW)
NCT01089751 (8) [back to overview]Percentage of Patients Continent (PPC)
NCT01166438 (5) [back to overview]Change From Baseline in Score on OABq-SF
NCT01166438 (5) [back to overview]Change in PFDI-SF and PFIQ-SF Total Scores
NCT01166438 (5) [back to overview]Change in Urge Urinary Incontinence (UUI) Episodes
NCT01166438 (5) [back to overview]Efficacy
NCT01166438 (5) [back to overview]Patient Global Impression of Improvement
NCT01178827 (8) [back to overview]Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
NCT01178827 (8) [back to overview]Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
NCT01178827 (8) [back to overview]Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
NCT01178827 (8) [back to overview]Plasma Levels of Sanctura XR® at Day 10 Post-dose
NCT01178827 (8) [back to overview]Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
NCT01178827 (8) [back to overview]Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
NCT01178827 (8) [back to overview]Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
NCT01178827 (8) [back to overview]Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
NCT01922115 (4) [back to overview]Hopkins Verbal Learning Test - Revised
NCT01922115 (4) [back to overview]Overactive Bladder Questionnaire
NCT01922115 (4) [back to overview]Mini-Mental State Examination
NCT01922115 (4) [back to overview]Hopkins Verbal Learning Test - Revised
NCT03697252 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Score
NCT03697252 (6) [back to overview]Percentage of Participants Who Were Clinical Global Impression - Severity of Illness (CGI-S) Responders
NCT03697252 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
NCT03697252 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
NCT03697252 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
NCT03697252 (6) [back to overview]Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
NCT04659161 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
NCT04659161 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Negative Score
NCT04659161 (6) [back to overview]Change From Baseline Clinical Global Impression - Severity (CGI-S) Score at Week 5
NCT04659161 (6) [back to overview]Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% Change in PANSS Total Score) at Week 5
NCT04659161 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
NCT04659161 (6) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5

Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose

The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid. (NCT00863551)
Timeframe: Day 10

InterventionPercentage of Subjects (Number)
Trospium Chloride Extended Release, 60 mgNA

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Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5

Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient. (NCT00863551)
Timeframe: Day 10, Hour 5

InterventionPicograms per milliliter (pg/mL) (Mean)
Trospium Chloride Extended Release, 60 mgNA

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Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). (NCT00863551)
Timeframe: Day 10

InterventionPercentage of Subjects (Number)
Trospium Chloride Extended Release, 60 mg100

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Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). (NCT00863551)
Timeframe: Day 10

InterventionPercentage of Subjects (Number)
Trospium Chloride Extended Release, 60 mg91.7

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Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose

The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid. (NCT00863551)
Timeframe: Day 10

InterventionPercentage of Subjects (Number)
Trospium Chloride Extended Release, 60 mgNA

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Percent Change From Baseline in Urinary Urgency Incontinence (UUI)

Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement. (NCT00932022)
Timeframe: Baseline (Week 2), Week 14

InterventionPercent change (Mean)
Trospium Chloride XR 60 mg-23.7
Placebo57.8

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Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®

Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® alone and in combination with Glucophage®. Plasma is the fluid portion of the blood in which the cells are suspended. (NCT00986401)
Timeframe: 34 Days

InterventionNanograms per milliliter (ng/mL) (Mean)
Sanctura XR®1.87
Sanctura XR® + Glucophage®1.17

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Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®

Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood. (NCT00986401)
Timeframe: 34 Days

InterventionNanograms per milliliter (ng/mL) (Mean)
Glucophage®739
Glucophage® + Sanctura XR®753

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Change From Baseline in Voided Volume

Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening. (NCT01089751)
Timeframe: Baseline, Week 14

,
Interventioncubic centimeters (cc) (Mean)
BaselineChange from Baseline at Week 14
Placebo187.4-8.0
Sanctura XR®183.520.6

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Change From Baseline in Urgency Urinary Incontinence (UUI)

"Urgency urinary incontinence is identified if the patient marks Yes for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement." (NCT01089751)
Timeframe: Baseline, Week 14

,
InterventionUUI episodes (Mean)
BaselineChange from Baseline at Week 14
Placebo3.0-0.6
Sanctura XR®2.9-1.1

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Change From Baseline in Urgency Severity

The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement. (NCT01089751)
Timeframe: Baseline, Week 14

,
InterventionScore on a scale (Mean)
BaselineChange from Baseline at Week 14
Placebo1.3-0.3
Sanctura XR®1.4-0.4

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Change From Baseline in Nocturic Toilet Voids

"A nocturic (nighttime) toilet void is identified if the patient marks Yes for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement." (NCT01089751)
Timeframe: Baseline, Week 14

,
InterventionNocturic toilet void (Mean)
BaselineChange from Baseline at Week 14
Placebo2.3-0.3
Sanctura XR®2.2-0.6

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Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)

The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores <= 30 indicate mild OAB, scores > 30 to 39 indicate moderate OAB, and scores >= 40 indicate severe OAB. A negative change from Baseline indicated improvement. (NCT01089751)
Timeframe: Baseline, Week 14

,
InterventionScore on a scale (Mean)
BaselineChange from Baseline at Week 14
Placebo23.7-3.4
Sanctura XR®24.6-6.5

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Change From Baseline in Continent Days Per Week (CDW)

Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement. (NCT01089751)
Timeframe: Baseline, Week 14

,
InterventionContinent days per week (Mean)
BaselineChange from Baseline at Week 14
Placebo1.01.3
Sanctura XR®0.82.6

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Percentage of Patients Continent (PPC)

PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit. (NCT01089751)
Timeframe: Week 14

InterventionPercentage of participants (Number)
Sanctura XR®34.6
Placebo17.1

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Change From Baseline in Score on OABq-SF

Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group. (NCT01166438)
Timeframe: Baseline through 6 months

,
InterventionChange from baseline in score on OABq-SF (Mean)
OABq-SF Symptom Severity ScoreOABq-SF Quality of Life Score
Botox A-44.0837.13
Standardized Anticholinergic Regimen-44.5537.05

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Change in PFDI-SF and PFIQ-SF Total Scores

Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings. (NCT01166438)
Timeframe: Baseline through 6 months

,
InterventionChanges in adjusted mean scores (Mean)
Change from baseline in PFDI-SF total scoreChange from baseline in PFIQ-SF total score
Botox A-48.20-33.85
Standardized Anticholinergic Regimen-43.69-32.82

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Change in Urge Urinary Incontinence (UUI) Episodes

Change from baseline in mean number of UUI episodes over 6 month double-blind period. (NCT01166438)
Timeframe: Baseline through 6 months

,
InterventionMean change in UUI episodes from baselin (Mean)
1 Month2 Months3 Months4 Months5 Months6 Months
Botox A-3.13-3.32-3.22-3.36-3.42-3.27
Standardized Anticholinergic Regimen-3.15-3.25-3.55-3.40-3.49-3.33

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Efficacy

Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI). (NCT01166438)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
Complete resolution of UUIComplete resolution of all incontinence>75% reduction in UUI episodes
Botox A302661
Standardized Anticholinergic Regimen161348

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Patient Global Impression of Improvement

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better). (NCT01166438)
Timeframe: 3 and 6 months

,
InterventionParticipants (Count of Participants)
Month 3Month 6
Botox A6160
Standardized Anticholinergic Regimen5967

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Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose

Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. (NCT01178827)
Timeframe: Day 2 Post-Dose

InterventionNanograms (ng) per milliliter (mL) (Mean)
OxybutyninN-Desethyl-Oxybutynin
Oxybutynin IR8.8047.0

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Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose

Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR. (NCT01178827)
Timeframe: Day 2 Post-Dose

InterventionNanograms (ng) per milliliter (mL) (Mean)
OxybutyninN-Desethyl-Oxybutynin
Oxybutynin IR0.05970.386

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Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose

Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®. (NCT01178827)
Timeframe: Day 10 Post-Dose

InterventionNanograms (ng) per milliliter (mL) (Mean)
Sanctura XR®NA

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Plasma Levels of Sanctura XR® at Day 10 Post-dose

Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. (NCT01178827)
Timeframe: Day 10 Post-Dose

InterventionNanograms (ng) per milliliter (mL) (Mean)
Sanctura XR®1.47

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Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10

Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. (NCT01178827)
Timeframe: Baseline, 10 Days

,,
InterventionScores on a Scale (Mean)
BaselineChange from Baseline up to Day 10
Oxybutynin IR8.0-1.8
Oxybutynin IR Placebo4.52.3
Sanctura XR®6.00.2

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Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10

Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. (NCT01178827)
Timeframe: Baseline, 10 Days

,,
InterventionScores on a Scale (Mean)
BaselineChange from Baseline up to Day 10
Oxybutynin IR9.4-1.3
Oxybutynin IR Placebo8.8-0.3
Sanctura XR®8.2-1.2

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Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10

Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory. (NCT01178827)
Timeframe: Baseline, 10 Days

,,
InterventionScores on a Scale (Mean)
BaselineChange from Baseline up to Day 10
Oxybutynin IR20.3-1.1
Oxybutynin IR Placebo16.80.0
Sanctura XR®15.81.2

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Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10

Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory. (NCT01178827)
Timeframe: Baseline, 10 Days

,,
InterventionScores on a Scale (Mean)
BaselineChange from Baseline up to Day 10
Oxybutynin IR24.4-3.3
Oxybutynin IR Placebo24.0-2.0
Sanctura XR®22.5-0.3

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Hopkins Verbal Learning Test - Revised

Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes. (NCT01922115)
Timeframe: Week 4

,
Interventionunits on a scale (Mean)
Immediate RecallDelayed Recall
PLACEBO24.387.83
TROSPIUM CHLORIDE22.006.71

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Overactive Bladder Questionnaire

The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes. (NCT01922115)
Timeframe: Week 4

Interventionunits on a scale (Mean)
TROSPIUM CHLORIDE41.45
PLACEBO56.04

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Mini-Mental State Examination

The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes. (NCT01922115)
Timeframe: Week 4

Interventionunits on a scale (Mean)
TROSPIUM CHLORIDE28.14
PLACEBO28.38

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Hopkins Verbal Learning Test - Revised

Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes. (NCT01922115)
Timeframe: Week 4

Interventionpercentage of total correct (Mean)
TROSPIUM CHLORIDE81.68
PLACEBO83.49

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Score

The Marder Negative Factor score is derived from the PANSS and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49. (NCT03697252)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-3.85
Placebo-1.32

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Percentage of Participants Who Were Clinical Global Impression - Severity of Illness (CGI-S) Responders

"The CGI-S modified asks the clinician 1 question: Considering your total clinical experience, how mentally ill is the participant at this time? The clinician's answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. A CGI-S responder is defined as a participant with a CGI-S scale equal to 1 or 2." (NCT03697252)
Timeframe: Week 5

Interventionpercentage of participants (Number)
KarXT5.6
Placebo1.4

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5

The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. (NCT03697252)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-17.40
Placebo-5.85

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5

The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The positive symptoms in schizophrenia are the excess or distortion of normal functions such as hallucinations, delusions, grandiosity, and hostility. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. (NCT03697252)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-5.62
Placebo-2.38

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5

The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. (NCT03697252)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-3.18
Placebo-0.90

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Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks

"The CGI-S modified asked the clinician 1 question: Considering your total clinical experience, how mentally ill is the participant at this time? The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants." (NCT03697252)
Timeframe: Baseline and Week 5

,
InterventionParticipants (Count of Participants)
Baseline: Score = 1Week 5: Score = 1Baseline: Score = 2Week 5: Score = 2Baseline: Score = 3Week 5: Score = 3Baseline: Score = 4Week 5: Score = 4Baseline: Score = 5Week 5: Score = 5Baseline: Score = 6Week 5: Score = 6Baseline: Score = 7Week 5: Score = 7
KarXT01030231321602110201
Placebo000107172160389412

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5

The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. (NCT04659161)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-3.4
Placebo-1.6

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Negative Score

The Marder Factor Negative Score is derived from the Positive and Negative Syndrome Scale (PANSS) and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. (NCT04659161)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-4.2
Placebo-2.0

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Change From Baseline Clinical Global Impression - Severity (CGI-S) Score at Week 5

"The CGI-S modified asked the clinician 1 question: Considering your total clinical experience, how mentally ill is the participant at this time? The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants." (NCT04659161)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-1.2
Placebo-0.7

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Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% Change in PANSS Total Score) at Week 5

The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 5. (NCT04659161)
Timeframe: Baseline and Week 5

InterventionParticipants (Count of Participants)
KarXT51
Placebo28

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5

The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. It takes approximately 45 to 50 minutes to administer. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. (NCT04659161)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-21.2
Placebo-11.6

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5

The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. (NCT04659161)
Timeframe: Baseline and Week 5

Interventionscore on a scale (Least Squares Mean)
KarXT-6.8
Placebo-3.9

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