Page last updated: 2024-10-15

beta-endorphin

Description

beta-Endorphin: A 31-amino acid peptide that is the C-terminal fragment of BETA-LIPOTROPIN. It acts on OPIOID RECEPTORS and is an analgesic. Its first four amino acids at the N-terminal are identical to the tetrapeptide sequence of METHIONINE ENKEPHALIN and LEUCINE ENKEPHALIN. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

beta-endorphin : A polypeptide consisting of 31 amino acid residues in the sequence Tyr-Gly-Gly-Phe-Met-Thr-Ser-Glu-Lys-Ser-Gln-Thr-Pro-Leu-Val-Thr-Leu-Phe-Lys-Asn-Ala-Ile-Ile-Lys-Asn-Ala-Tyr-Lys-Lys-Gly-Glu. It is an endogenous opioid peptide neurotransmitter found in the neurons of both the central and peripheral nervous system and results from processing of the precursor protein proopiomelanocortin (POMC). [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 CID16132316
CHEMBL ID1866903
SCHEMBL ID6238339
MeSH IDM0002414

Synonyms (21)

Synonym
gtpl1643
einecs 262-330-3
beta-endorphin
beta-endorphin human, >=95% (hplc)
NCGC00163196-01
NCGC00163196-02
61214-51-5
unii-3s51p4w3xq
3s51p4w3xq ,
27-l-tyrosine-31-l-glutamic acid-beta-endorphin (sheep)
beta-endorphin (sheep), 27-l-tyrosine-31-l-glutamic acid-
SCHEMBL6238339
CHEMBL1866903
mfcd00076383
beta-endorphin human synthetic
F82167
DTXSID30210135
beta-endorphin (human synthetic)
AS-83086
AKOS040740635
??-endorphin, human

Pharmacokinetics

ExcerptReference
"In order to simulate the distribution and elimination of radioiodinated human beta-endorphin (125I-beta-EP) after iv bolus injection in rats, we proposed a physiologically based pharmacokinetic model incorporating diffusional transport of 125I-beta-EP across the capillary membrane."( Physiologically based pharmacokinetics of radioiodinated human beta-endorphin in rats. An application of the capillary membrane-limited model.
Hanano, M; Iga, T; Sato, H; Sawada, Y; Sugiyama, Y,
)
" Pharmacokinetic analysis of pharmacologically active beta-EP equivalents (beta-EP eq."( Pharmacokinetic study of exogenously administered beta-endorphin using a rapid radioreceptor assay in rats.
Hanano, M; Iga, T; Sato, H; Sawada, Y; Sugiyama, Y, 1984
)

Compound-Compound Interactions

We measured beta-endorphin (beta-EP) and cortisol contents in thyroidectomy under acupuncture analgesia (12 cases) and acupuncture anesthesia combined with tetrahydropalmatine. Oxytocin in combination with CRH exerted an additive effect on beta- endorphin secretion during the luteal phase.

ExcerptReference
"Stress hormone response was investigated during midazolam/fentanyl/oxygen/air anesthesia combined with epidural anesthesia in six patients undergoing abdominal total hysterectomy (group MF)."( [Stress hormone response during midazolam/fentanyl anesthesia combined with epidural anesthesia for abdominal total hysterectomy].
Honda, N; Kitano, T; Miyakawa, H; Mizutani, A; Taniguchi, K; Yoshitake, S, 1996
)
" We measured beta-endorphin (beta-EP) and cortisol contents in thyroidectomy under acupuncture analgesia (12 cases) and acupuncture anesthesia combined with tetrahydropalmatine (12 cases) by RIA."( [Alterations of plasma beta-EP and cortisol contents in thyroidectomy under acupuncture anesthesia and acupuncture anesthesia combined with tetrahydropalmatine].
Xu, Z; Zhu, W, 1996
)
" In this study, mice were subjected to handling combined with rectal temperature measurement (RTM) stress or handling only stress."( Cytokine and hormone profiles in mice subjected to handling combined with rectal temperature measurement stress and handling only stress.
Gauthier, DK; Ghanta, VK; Hale, KD; Hiramoto, RN; Weigent, DA, 2003
)
" Oxytocin in combination with CRH exerted an additive effect on beta-endorphin secretion during the luteal phase."( Effects of oxytocin alone and in combination with selected hypothalamic hormones on ACTH, beta-endorphin, LH and PRL secretion by anterior pituitary cells of cyclic pigs.
Bogacka, I; Franczak, A; Kotwica, G; Kraziński, B; Kurowicka, B; Okrasa, S; Siawrys, G; Skowroński, MT; Staszkiewicz, J, 2006
)
"To evaluate the effects of patient-controlled analgesia (PCA) with small dose ketamine combined with morphine on analgesia and influence thereof on the plasma beta-endorphin (EP) level in the patients after radical operation for esophageal carcinoma."( [Effects of patient-controlled analgesia with small dose ketamine combined with morphine and the influence thereof on plasma beta-endorphin level in patients after radical operation for esophageal carcinoma].
Feng, J; Huang, XM; Li, H; Ma, LY; Wu, YQ; Xiong, JC; Xu, ZM; Zhang, DT, 2009
)
"To evaluate the effects of xylazole (an analogue of xylazine), also known as Jingsongling, alone and in combination with ketamine, on metabolic and neurohumoral responses in healthy dogs."( Effects of xylazole alone and in combination with ketamine on the metabolic and neurohumoral responses in healthy dogs.
Changmin, H; Dongming, L; Guohong, L; Jianguo, C; Mingxing, D, 2010
)
"This study demonstrates that xylazole administered alone or in combination with ketamine in healthy dogs results in physiological, metabolic and neurohumoral responses similar to those seen after xylazine."( Effects of xylazole alone and in combination with ketamine on the metabolic and neurohumoral responses in healthy dogs.
Changmin, H; Dongming, L; Guohong, L; Jianguo, C; Mingxing, D, 2010
)
" In this study, we proposed that I-gel combined with tracheal intubation could reduce the stress response of posterior fossa surgery patients."( I-gel Laryngeal Mask Airway Combined with Tracheal Intubation Attenuate Systemic Stress Response in Patients Undergoing Posterior Fossa Surgery.
Chai, X; Hou, T; Huang, X; Kang, F; Li, J; Tang, C; Tang, F, 2015
)
"Utilization of I-gel combined with endotracheal tube in posterior fossa surgery patients is safe which can yield more stable hemodynamic profile during intubation and emergence and lower inflammatory and oxidative response, leading to uneventful recovery."( I-gel Laryngeal Mask Airway Combined with Tracheal Intubation Attenuate Systemic Stress Response in Patients Undergoing Posterior Fossa Surgery.
Chai, X; Hou, T; Huang, X; Kang, F; Li, J; Tang, C; Tang, F, 2015
)
"EA intervention combined with anesthetics is effective in reducing the dosage of the supplemented Sauteralgyl and the degree of postoperative nausea, and in improving postoperative gastrointestinal functional recovery in patients undergoing pneumectomy."( [Electroacupuncture Intervention Combined with Anesthetics for Analgesia and Post-surgical Gastrointestinal Recovery in Pneumectomy Patients].
Chen, TY; Ma, W; Wang, K; Wu, YY; Xu, JJ; Zhou, J, 2015
)
"To explore the application of Chaihu-Guizhi-Longgu-Muli decoction (CGLM) combined with Liuwei Dihuang Pills in the treatment of menopausal insomnia and its effect on sleep quality."( Application of Chaihu-Guizhi-Longgu-Muli decoction combined with Liuwei Dihuang Pills in the treatment of menopausal insomnia and its effect on sleep quality.
Xu, L; Xu, Y; Zheng, Y, 2021
)

Bioavailability

ExcerptReference
"The stability of the neuroleptic peptide des-enkephalin-gamma-endorphin (DE gamma E; Org 5878) in the rectal lumen and the rectal bioavailability of DE gamma E were investigated in conscious rats."( Rectal absorption enhancement of des-enkephalin-gamma-endorphin (DE gamma E) by medium-chain glycerides and EDTA in conscious rats.
Breimer, DD; de Boer, AG; Heijligers-Feijen, CD; van Hoogdalem, EJ; Verhoef, JC, 1989
)
" The bioavailability of DE gamma E for this route of administration was shown to be 20-23%."( Des-enkephalin-gamma-endorphin (DE gamma E): pharmacokinetics in dogs after intravenous and subcutaneous administration.
van den Wildenberg, HM; Verhoef, J,
)
" Hence, improvement of the transdermal bioavailability of the peptide will most likely be obtained chiefly by enhancing its flux (possibly through iontophoresis), intra(epi-)dermal degradation being a problem of only minor importance."( Transdermal peptide delivery.
Bodde, HE; Ponec, M; Verhoef, JC, 1989
)
" The absolute bioavailability of DE gamma E after subcutaneous injection amounted to 30."( Des-enkephalin-gamma-endorphin: bioavailability in rats following the subcutaneous and intramuscular route of administration.
van den Wildenberg, HM; Verhoef, JC, 1986
)

Dosage Studied

Antagonism by competition at the same site(s) is suggested. Time- and dose-response curves were obtained in beta-endorphin-deficient and matched wild-type C57BL/6 congenic mice using the tail-immersion/withdrawal assay.

ExcerptReference
" In a dose-response study, maximally effective doses of di-ac-alpha MSH and N-ac-beta END were equally effective with respect to their function as lactotrope-recruiting factors."( N-acetylation is required for the lactotrope recruitment activity of alpha-melanocyte-stimulating hormone and beta-endorphin.
Ellerkmann, E; Frawley, LS; Nagy, GM; Porter, TE, 1992
)
"This study defines the pituitary B-endorphin (BE) secretory response to a low dosage (0."( B-endorphin response to a low dosage of human corticotropin releasing hormone during metyrapone administration in depression.
Brazis, M; Dorin, R; Hauger, R; Lisansky, J; Meikle, AW; Qualls, C; Strassman, R; Turkin, A, 1992
)
" After exposure to various concentrations of ethanol, it was observed that for both strains of mice, low concentrations of ethanol (10, 20 and 25 mM) induced a more pronounced increase in the release of hypothalamic beta-EP than high concentrations of ethanol (30 and 60 mM) leading to an inverse U-shaped dose-response curve."( The alcohol-preferring C57BL/6 mice present an enhanced sensitivity of the hypothalamic beta-endorphin system to ethanol than the alcohol-avoiding DBA/2 mice.
De Waele, JP; Gianoulakis, C; Papachristou, DN, 1992
)
" The dose-response curves for induction of behavior was very different from that for increasing the concentration of i beta-E in plasma."( Phencyclidine increased release of beta-endorphin from anterior lobe of the pituitary.
Contreras, PC; Farah, JM; Jacobson, AE; Rice, KC, 1991
)
" Further research is needed to confirm longer term efficacy (in particular, effects on fracture rate), optimal dosage schedules and the role of intermittent and combination treatment regimens."( Intranasal salmon calcitonin. A review of its pharmacological properties and potential utility in metabolic bone disorders associated with aging.
Chrisp, P; Clissold, SP; Fitton, A,
)
"We investigated the acute, dose-response to three intranasal doses of salmon calcitonin (sCT) (50 IU, 100 IU, and 200 IU) and one im dose (50 IU) in eight premenopausal and eight early postmenopausal women."( Dose-response bioactivity and bioavailability of salmon calcitonin in premenopausal and postmenopausal women.
Agnusdei, D; Christiansen, C; Gennari, C; Hansen, MA; Maioli, E; Overgaard, K, 1991
)
" Alcohol time- and dose-response curves were constructed for changes in TIF volume and the bioactive concentrations of testosterone and immunoreactive beta E (i-beta E)."( Alcohol affects rat testicular interstitial fluid volume and testicular secretion of testosterone and beta-endorphin.
Adams, ML; Bell, B; Cicero, TJ; Little, PJ, 1991
)
" Dose-response studies demonstrated that higher doses (greater than 1 microgram) of morphine IC were required to block TRH-induced increases in preweaning rats."( Morphine inhibits TRH-induced intestinal transit increases.
Bond, EF; Heitkemper, MM,
)
" While the higher dosage of analgesics administered intraoperatively resulted in markedly lower plasma concentrations of beta-endorphin, there was no such effect in the postoperative phase."( [The quality of analgesia in relation to the plasma concentration of beta-endorphin during neuroleptanalgesia and epidural analgesia].
Krug, G; Meltonjan, G; Rathsack, R; Schädlich, M; Schöntube, E, 1990
)
" On day 6, the magnitude of tolerance was assessed by establishing IT dose-response lines for the effect of the chronic drug given as bolus injections (probe)."( Tolerance to delta- but not mu-opioid receptors in the spinal cord attenuates inhibition of the tail-flick response induced by beta-endorphin administered intracerebroventricularly in mice.
Suh, HH; Tseng, LF, 1990
)
"In the first experiment a conditioned taste aversion paradigm was used to characterize a dose-response curve for the aversive properties of nicotine in male Sprague-Dawley rats."( Characterization of a dose-response curve for nicotine-induced conditioned taste aversion in rats: relationship to elevation of plasma beta-endorphin concentration.
Gilbert, DG; Jensen, RA; Landrum, TA; Meliska, CJ; Szary, AB, 1990
)
"05) by GnRH compared to control, but the dose-response to GnRH was absent."( Opioid modulation of LH secretion by pig pituitary cells in vitro.
Barb, CR; Barrett, JB; Kraeling, RR; Rampacek, GB; Wright, JT, 1990
)
" gamma E (beta-LPH-(61-77)), beta-endorphin-(1-17)), and DT gamma E (beta-LPH-(62-77), beta-endorphin-(2-17)) were without effect in the dosage used."( The effect of gamma-type endorphins on alpha-MSH release in the rat.
Andringa-Bakker, EA; de Rotte, AA; de Wied, D; van de Buuse, M; van Wimersma Greidanus, TB, 1985
)
" Both peptides shifted the FSH dose-response curve to the left, making the cells more sensitive to this gonadotropin."( Stimulation of adenosine 3',5'-monophosphate production in rat Sertoli cells by alpha-melanotropin-stimulating hormone (alpha MSH) and des-acetyl alpha MSH.
Bardin, CW; Boitani, C; Mather, JP, 1986
)
" A U-shaped dose-response relation was observed."( Beta-endorphin and related peptides suppress phorbol myristate acetate-induced respiratory burst in human polymorphonuclear leukocytes.
de Wied, D; Diamant, M; Henricks, PA; Nijkamp, FP, 1989
)
"After intravenous dosing in dogs [3H-Lys9]-DE gamma E (Org 5878) was very rapidly eliminated from the circulation."( Des-enkephalin-gamma-endorphin (DE gamma E): pharmacokinetics in dogs after intravenous and subcutaneous administration.
van den Wildenberg, HM; Verhoef, J,
)
" In some cases, effective transdermal dosing has been achieved in vivo, especially with the aid of iontophoresis."( Transdermal peptide delivery.
Bodde, HE; Ponec, M; Verhoef, JC, 1989
)
" For blood pressure and heart rate, pretreatment with a midportion beta-endorphin antiserum resulted in a parallel shift to the right of the dose-response curve for alpha-methyldopa."( Possible involvement of beta endorphin(1-31) and dynorphin(1-13) in the central hypotensive mechanism of action of alpha methyldopa.
de Jong, W; van Giersbergen, PL; Wiegant, VM, 1989
)
" These are characterized by the slope of the dose-response curve for the substances to antagonize the apomorphine-induced behavioral effects and by the effectiveness of DE gamma E in this respect."( Antipsychotic substances and dopamine in the rat brain; behavioral studies reveal distinct dopamine receptor systems.
Elands, J; Király, I; Van Ree, JM; Wolterink, G, 1989
)
" Adult female monkeys dosed po with 5 or 10 mg/kg of MDMA twice/day for 4 consecutive days demonstrated no spontaneous behavioral changes or weight loss compared to controls, but forebrain 5-HT concentration was reduced by 80% 1 mon after dosing."( Behavioral and neurochemical effects of orally administered MDMA in the rodent and nonhuman primate.
Ali, SF; Bailey, JR; Holson, RR; Hong, JS; Kolta, MG; McMillan, DE; Paule, MG; Scallet, AC; Scalzo, FM; Slikker, W, 1989
)
" Dose-response studies showed that the behavioural effect of such mixtures depended upon the molar ratios of the two peptides, rather than their absolute concentrations."( The effects of simultaneous or separate infusions of some pro-opiomelanocortin-derived peptides (beta-endorphin, melanocyte stimulating hormone, and corticotrophin-like intermediate polypeptide) and their acetylated derivatives upon sexual and ingestive b
Everitt, BJ; Herbert, J; Hughes, AM, 1988
)
" There is an inverse dose-response relation for PMN but not PMO."( Opioid peptides rapidly stimulate superoxide production by human polymorphonuclear leukocytes and macrophages.
Gekker, G; Keane, WF; Peterson, PK; Sharp, BM; Suh, HJ; Tsukayama, D, 1985
)
" TD was not related to age, age at onset of illness, duration of illness, dosage and type of neuroleptics, number of ECTs, or any endocrine variable."( Tardive dyskinesia: relation to computer-tomographic, endocrine, and psychopathological variables.
Ackenheil, M; Albus, M; Douillet, P; Müller-Spahn, F; Naber, D; Reinertshofer, T, 1985
)
"6) of 47 +/- 11 years of age, treated with neuroleptics for the last 16 +/- 6 years: Age, age at first manifestation of disease, duration and dosage scheme of neuroleptic therapy and number of electroconvulsive shock treatments."( [Psychopathologic changes in chronic schizophrenic patients following withdrawal of neuroleptics: relation to therapeutic, neuroendocrine and computer tomography variables].
Ackenheil, M; Albus, M; Bürke, H; Müller-Spahn, F; Münch, U; Naber, D; Reinertshofer, T; Schmidt-Vanderheyden, W; Weber, G; Wissmann, J, 1986
)
" The slope of the dose-response curve was steeper after pre-exposure."( Behavioral effects of morphine and phencyclidine in rats: the influence of repeated testing before and after single treatment.
Leys, A; Van Ree, JM, 1985
)
" An inverted-U dose-response curve was obtained."( Pharmacological evidence of a central effect of naltrexone, morphine, and beta-endorphin and a peripheral effect of met- and leu-enkephalin on retention of an inhibitory response in mice.
Baratti, CM; Introini, IB; McGaugh, JL, 1985
)
" A dose-response relationship between inhibition of alpha-MSH secretion and the concentration of Leu-enkephalin, with ED50 approximately 10(-9) M, was observed."( Modulation by Leu-enkephalin of peptide release from perifused neurointermediate pituitary. II. Inhibition of calcium-mediated secretion of alpha-MSH and beta-endorphin.
Al Zein, M; Koch, B; Lutz-Bucher, B, 1986
)
"Therapeutic plasma monitoring of haloperidol, a major neuroleptic, measured by radioimmunoassay, has shown a rather good correlation between plasma level and dosage but with large interindividual variation in children as in adults; age seems not to have any effect on haloperidol metabolism."( [Haloperidol. Plasma monitoring and hormonal effects of treatment].
Debray, Q; Dugas, M; Giraud, J; Goyot, C; Grenier, J; Guay, C, 1985
)
" Time-course and dose-response studies further demonstrated that acetyltransferase activity covaried with POMC mRNA and peptide levels."( Coordinate regulation of peptide acetyltransferase activity and proopiomelanocortin gene expression in the intermediate lobe of the rat pituitary.
Chappell, MC; Millington, WR; Mueller, GP; O'Donohue, TL; Roberts, JL, 1986
)
" These effects were dose related, with the pyloric dose-response profile being essentially linear."( Dose-related effects of synthetic human beta-endorphin and naloxone on fed gastrointestinal motility.
Camilleri, M; Kao, PC; Li, CH; Malagelada, JR; Stanghellini, V; Zinsmeister, AR, 1986
)
" Complete dose-response data for morphine, heroin, etorphine, d- and l-ethylketazocine, d- and l-pentazocine, and d- and l-N-allylnormetazocine revealed a predominant response of hyperthermia."( Body temperature effects of opioids in rats: intracerebroventricular administration.
Adler, MW; Geller, EB; Rowan, CH, 1986
)
" Pretreatment with the opiate receptor antagonist naltrexone resulted in a parallel shift to the right of the dose-response curve for alpha-methyldopa, both for blood pressure and heart rate."( Antagonism by naltrexone of the hypotension and bradycardia induced by alpha-methyldopa in conscious normotensive rats.
de Jong, W; van Giersbergen, PL, 1988
)
" Total plasmatic beta-endorphin (BEP) and its precursor beta-lipotropin (BLPH) were dosed by radioimmunoassay at rest, at 60% VO2max, at 80% VO2max and after complete recovery."( [Release of beta-endorphin and beta-lipotropin during submaximal exertion in sedentary and active subjects. Endogenous opiate peptides during exertion in sedentary and active subjects].
Fanelli, R; Ficola, U; Loperfido, F; Perna, GP; Stanislao, M; Varraso, A; Villella, A, 1987
)
" Synthetic beta-lipotropin (5 x 10(-10) mol/l) did not significantly change the dose-response curve for corticotropin (10(-13) mol/l-10(-9) mol/l) versus the three steroids measured."( Effects of beta-lipotropin, beta-endorphin, gamma 2-melanotropin and corticotropin on steroid production by isolated human adrenocortical cells.
Bähr, V; Eggens, U; Li, CH; Oelkers, W, 1987
)
" Antagonism by competition at same opioid receptor subtypes is suggested from parallel shifts of the dose-response curve of etorphine or beta h-EP in the presence of increasing doses of beta h-EP-(1-28)."( Inhibition of analgesia by C-terminal deletion analogs of human beta-endorphin.
Li, CH; Nicolas, P, 1985
)
"The threshold and dose-response relationships for the blood pressure and metabolic effects of adrenocorticotropic hormone (corticotropin, ACTH) were examined in conscious sheep."( Onset and dose relationships of ACTH effects on blood pressure in sheep.
Allen, KJ; Coghlan, JP; Denton, DA; Fei, DT; Scoggins, BA; Tresham, JJ; Wang, XM; Whitworth, JA,
)
" There was no dose response relationship between the injected oCRF dosage and stimulated ACTH, beta-endorphin, and cortisol secretion."( Corticotropin releasing factor (CRF): diagnostic implications.
Hartwimmer, J; Müller, OA; Schopohl, J; Stalla, GK; von Werder, K, 1985
)
" Antagonism by competition at the same site(s) is suggested from parallel shifts of the dose-response curves of etorphine or beta-endorphin in the presence of beta-endorphin-(1-27)."( Beta-endorphin-(1-27) is a naturally occurring antagonist to etorphine-induced analgesia.
Li, CH; Nicolas, P, 1985
)
" In dose-response experiments, the minimum concentration of CRF in a 10-min pulse required to significantly raise the output of ACTH was 200 pM, and initial responses had not attained maximal levels with concentrations of CRF increased to 2 microM."( The effect of various corticotropin-releasing factor trains on the release of adrenocorticotropin, beta-endorphin, and beta-lipotropin from perifused ovine pituitary cells.
Brett, JT; Donald, RA; Evans, MJ; Livesey, JH; McIntosh, JE; McIntosh, RP; Roud, HK, 1985
)
"1 micrograms/kg, ip) exerted effects opposite to those elicited by naloxone, that is, shifted the dose-response curve of clenbuterol to the right."( Opioid peptidergic systems modulate the activity of beta-adrenergic mechanisms during memory consolidation processes.
Baratti, CM; Introini-Collison, IB, 1986
)
" The accumulation of O2- in response to the potent chemotactic peptide formyl-methionine-leucine-phenylalanine was studied and a distinctly different dose-response profile with a peak response at 10(-8) M was observed."( Beta-endorphin stimulates human polymorphonuclear leukocyte superoxide production via a stereoselective opiate receptor.
Gekker, G; Keane, WF; Peterson, PK; Sharp, BM; Tsukayama, DT, 1987
)
" Dosing rates and rankings of pain, sedation, and liking decreased as a function of time postoperatively, but respiratory rates did not."( Relationship between plasma morphine concentrations and pharmacologic effects in postoperative patients using patient-controlled analgesia.
Arrigo, JM; Batenhorst, RL; Baumann, TJ; Foster, TS; Graves, DA,
)
" In the present study, we infused beta h-endorphin into six normal subjects under carefully controlled conditions at dosage levels several orders of magnitude higher than endogenous levels."( Effect of human beta-endorphin on plasma aldosterone concentrations in normal human subjects.
Feldman, M; Kem, DC; Li, CH; Starkweather, G, 1985
)
"1 micrograms/kg X min dosage levels."( beta-Endorphin stimulates plasma renin and aldosterone release in normal human subjects.
Dluhy, RG; Rabinowe, SL; Taylor, T; Williams, GH, 1985
)
" In general, opioid mechanisms sensitive to the present dosage of naloxone do not appear to mediate bacteremia-induced changes in hormonal or clinical parameters."( Bacteremia-induced changes in pituitary hormone release and effect of naloxone.
Leshin, LS; Malven, PV, 1984
)
" A positive dose-response relationship existed between the concentration of cholera toxin and the release of beta-END-LIS or the accumulation of cAMP."( [The effects of cholera toxin in the release of beta-endorphin from the dispersed cells of the rat neurointermediate lobe].
Furuki, Y; Hatada, Y; Maeyama, M; Matsumura, M; Munemura, M; Sakoda, Y, 1984
)
" Thus, the dose-response curve shows an U-shaped form."( The impairment of retention induced by beta-endorphin in mice may be mediated by a reduction of central cholinergic activity.
Baratti, CM; Introini, IB, 1984
)
" In the presence of 30 microM morphine, the dose-response curve of beta-endorphin shifted to the right by about 10-fold."( Partial agonistic action of morphine in the rat vas deferens.
Ishii, K; Kato, R; Muraki, T; Yamamoto, S, 1981
)
"2-200 mug/d) concurrently suppressed plasma ir-ACTH and ir-betaEP, with a near maximal effect at 20 mug, and a half-maximal effect between 2 and 6 mug; similar dose-response characteristics were found for thymolysis."( Glucocorticoid and mineralocorticoid effects on adrenocorticotropin and beta-endorphin in the adrenalectomized rat.
Clements, J; Funder, JW; Khalid, BA; Lim, AT, 1982
)
" Unilateral injection resulted in a U-shaped dose-response relationship with a fall in mean arterial pressure and heart rate occurring at low doses (less than 10 ng)."( Cardiovascular effects of beta-endorphin after microinjection into the nucleus tractus solitarii of the anaesthetised rat.
De Jong, W; Petty, MA, 1982
)
" The duration of analgesia and the slope of the dose-response curves generated by these peptides are similar to those elicited by mammalian beta-endorphins."( beta-Endorphin: analgesic and receptor binding activity of non-mammalian homologs.
Hammonds, RG; Li, CH; Nicolas, P, 1982
)
") shifted the dose-response curve for both responses to the right more for the beta-EP than for DADL."( Inhibition of tail-flick and shaking responses by intrathecal and intraventricular D-Ala2-D-Leu5-enkephalin and beta-endorphin in anesthetized rats.
Cheng, SS; Fujimoto, JM; Tseng, LF, 1983
)
" Dose-response curves were plotted with naloxone against the changes produced by each agonist, and the effect of a number of anticonvulsant drugs on agonist-induced seizures was ascertained."( The epileptogenic spectrum of opiate agonists.
Bearden, LJ; Snead, OC, 1982
)
" It increased the IC50 values and slopes of their dose-response curve for enkephalins and their analogs, and shifted to the right the curves for FK33824, levorphanol and normorphine."( Functional opiate receptor in mouse vas deferens: evidence for a complex interaction.
Garzón, J; Lee, NM; Sánchez-Blázquez, P, 1983
)
" Dose-response studies indicated a rank order of CRA as follows: CRF greater than AVP greater than OXY greater than AII = AIII."( Angiotensin II and ACTH release: site of action and potency relative to corticotropin releasing factor and vasopressin.
Negro-Vilar, A; Spinedi, E, 1983
)
" Some improvements were observed after 1 week of treatment; the most improvement occurred at 6 weeks, when the mean doxepin dosage was approximately 200 mg/day and plasma doxepin and nordoxepin averaged 80 ng/ml."( Doxepin's effects on chronic pain and depression: a controlled study.
Cork, RC; Crago, BR; Davis, TP; Hameroff, SR; Lerman, JC; Neuman, CP; Watts, KS; Weiss, JL; Womble, JR, 1984
)
" A parallel shift in the dose-response curve of beta h-endorphin in the presence of beta h-endorphin-(1-27) suggests competition at the same site."( beta-endorphin-(1-27) is an antagonist of beta-endorphin analgesia.
Hammonds, RG; Li, CH; Nicolas, P, 1984
)
" A parallel shift of the dose-response curve for analgesia to the right was observed when either beta h-EP or [ Trp27 ] -beta h-EP was coinjected with various doses of [Gln8, Gly31 ]-beta h-EP-Gly-Gly-NH2, [Arg9,19,24,28,29]-beta h-EP, or [ Cys11 ,26, Phe27 , Gly31 ]-beta h-EP."( beta-Endorphin-induced analgesia is inhibited by synthetic analogs of beta-endorphin.
Hammonds, RG; Li, CH; Nicolas, P, 1984
)
" A dose-response study revealed a U-shaped relationship for this effect of beta E 2-9 in animals of both sexes."( The stimulatory effect of a non-opiate beta-endorphin fragment on arginine-vasopressin release in rats.
de Wied, D; Laczi, F; Sykes, JE; Wiegant, VM, 1984
)
" There was no dose-response relationship between the injected oCRF dosage and stimulated ACTH, beta-endorphin, and cortisol secretion."( Ovine (o) and human (h) corticotrophin releasing factor (CRF) in man: CRF-stimulation and CRF-immunoreactivity.
Hartwimmer, J; Müller, OA; Stalla, GK; von Werder, K, 1984
)
" The response to DE gamma E appeared to be negatively correlated with the dosage of neuroleptic medication and the duration of the last psychotic episode."( Antipsychotic properties of Des-enkephalin-gamma-endorphin in treatment of schizophrenic patients.
de Wied, D; Heezius-van Bentum, A; van Praag, HM; van Ree, JM; Verhoeven, WM, 1982
)
" The gamma-type endorphin exhibited an inverted U-shaped dose-response curve on passive avoidance behavior but not on extinction of pole-jumping avoidance behavior."( Effect of des-Tyr1-gamma-endorphin and des-enkephalin-gamma-endorphin on active and passive avoidance behavior of rats; a dose-response relationship study.
De Wied, D; Gaffori, O, 1982
)
" This effect was noncompetitive as the slopes for the antinociceptive dose-response curves diminished after SP pretreatment."( N-acetyl beta-endorphin-(1-31) and substance P regulate the supraspinal antinociception mediated by mu opioid and alpha-2 adrenoceptors but not by delta opioid receptors in the mouse.
Garzón, J; Sánchez-Blázquez, P, 1993
)
" A dose-response relationship between CRH and the hormones measured was found in patients and controls."( Stimulation of the pituitary-adrenal system with graded doses of CRH and low dose vasopressin infusion in depressed patients and healthy subjects: a pilot study.
Gispen-de Wied, CC; Kok, FW; Koppeschaar, HP; Thijssen, JH; van Ree, JM; Westenberg, HG; Wynne, HJ, 1993
)
" One alternative is the combination of glycopyrrolate, alfentanil and suxamethonium described here, although the ideal medication and dosage still remain to be defined."( Physiological changes, plasma beta-endorphin and cortisol responses to tracheal intubation in neonates.
Koivisto, M; Pokela, ML, 1994
)
"To begin applying basic neuropharmacological hypotheses of hallucinogenic drug actions to humans, we generated dose-response data for intravenously administered dimethyltryptamine fumarate's (DMT) neuroendocrine, cardiovascular, autonomic, and subjective effects in a group of experienced hallucinogen users."( Dose-response study of N,N-dimethyltryptamine in humans. I. Neuroendocrine, autonomic, and cardiovascular effects.
Qualls, CR; Strassman, RJ, 1994
)
"Dimethyltryptamine can be administered safely to experienced hallucinogen users and dose-response data generated for several measures hypothesized under serotonergic modulatory control."( Dose-response study of N,N-dimethyltryptamine in humans. I. Neuroendocrine, autonomic, and cardiovascular effects.
Qualls, CR; Strassman, RJ, 1994
)
" The primary physician was allowed to titrate the dosage as required to meet the patient's requirement for analgesia."( Relationship between pain severity and serum beta-endorphin levels in postoperative patients.
Asher, MA; Klem, SA; Leff, RD; Leonard, TM; Rapoff, MA,
)
" Dose-response curve for naloxone inhibition of intake was shifted leftward in obese compared with lean sheep."( Feeding behavior and its responsiveness to naloxone differ in lean and obese sheep.
Alavi, FK; Mauromoustakis, A; McCann, JP; Sangiah, S, 1993
)
" A naltrexone-insensitive component to beta-endorphin antinociception also was identified in studies which evaluated the ability of the antagonist to shift the beta-endorphin dose-response curve."( Biochemical and pharmacological characterization of multiple beta-endorphinergic antinociceptive systems in the rat periaqueductal gray.
Hawranko, AA; Monroe, PJ; Smith, DJ; Smith, DL, 1996
)
" The effects of beta-endorphin were eliminated by dosage with naloxone."( Comparative study of the roles of ACTH and beta-endorphin in regulating conditioned reflex activity in the hedgehog.
Sollertinskaya, TN,
)
" the dose-response curve is bell-shaped."( The C-terminal tetrapeptide of beta-endorphin (MPF) enhances lymphocyte proliferative responses.
Ensor, DM; Miles, JB; Morley, JS; Owen, DL, 1998
)
" Adult male rats received subcutaneous injections of either nicotine or saline during the dark period of each day on an increasing frequency (1-3 injections/day) and dosage (0."( Effects of chronic nicotine treatment and withdrawal on hypothalamic proopiomelanocortin gene expression and neuroendocrine regulation.
Rasmussen, DD, 1998
)
" A dose-response relationship was identified for lordosis in experimental animals receiving icv injection of beta-EP."( Facilitatory and inhibitory effects of beta-endorphin on lordosis in female rats: relation to time of administration.
Kubo, K; Sasaki, T; Torii, M, 1999
)
" However, the flatter dose-response slope for TRH compared with BHE or the small amounts of VIP and END in BHE suggested that these peptides could not account for the major active elements of BHE."( Multiple prolactin-releasing activity in the bovine hypothalamic extract.
Kubokawa, M; Nakamura, K; Sato, F; Yasuda, N, 2000
)
" Dose-response curves constructed from the data indicated that the antinociceptive effect of nitrous oxide was significantly antagonized by antisera to various dynorphins (DYNs) and methionine-enkephalin (ME), but not by antiserum to beta-endorphin (beta-EP)."( Antagonism of nitrous oxide antinociception in mice by intrathecally administered antisera to endogenous opioid peptides.
Cahill, FJ; Ellenberger, EA; Mueller, JL; Quock, RM; Tseng, LF,
)
" Time- and dose-response curves were obtained in beta-endorphin-deficient and matched wild-type C57BL/6 congenic control mice using the tail-immersion/withdrawal assay."( Disparate spinal and supraspinal opioid antinociceptive responses in beta-endorphin-deficient mutant mice.
Bales, JR; Belknap, JK; Grisel, JE; Hayward, MD; Low, MJ; Mogil, JS; Rubinstein, M, 2000
)
" Group I was the group of animal model of Yang deficiency; Group II was the ikaclomine treatment group; Group III was the high dosage treatment group; Group IV was the low dosage group; Group V normal rabbit treated with distilled water."( [Effect of Yangxue bushen tablet on ovarian function in animal model of Yang deficiency].
Cai, L; Li, H; Wei, Y, 1998
)
"First, intranasal beta-endorphin challenges with subsequent lavages to determine histamine and albumin levels and measurements of nasal flow and resistance in dose-response and time course experiments were performed."( Effects of beta-endorphin on nasal allergic inflammation.
Baumgarten, CR; Kunkel, G; O'Connor, A; Schmitz, P, 2002
)
" However, simultaneous administration of similar dosage of FSH and beta-EP (0."( Beta-endorphin disrupts seasonal and FSH-induced ovarian recrudescence in the lizard Mabuya carinata.
Ganesh, CB; Yajurvedi, HN, 2003
)
" The lowest dosage of NTX significantly reduced SIB in subjects with baseline levels of beta-E higher than after SIB."( beta-Endorphin and ACTH are dissociated after self-injury in adults with developmental disabilities.
Chicz-DeMet, A; Lenjavi, M; Marion, S; Sandman, CA; Touchette, P, 2003
)
" Puerarin at the effective dosage to lower higher plasma glucose increased plasma beta-endorphin-like immunoreactivity (BER) in STZ-diabetic rats."( Mediation of beta-endorphin by the isoflavone puerarin to lower plasma glucose in streptozotocin-induced diabetic rats.
Chen, WC; Cheng, JT; Hayakawa, S; Liu, IM; Su, HC; Yamamoto, T, 2004
)
" Further, a cocaine dose-response demonstrates that the increased lever presses in anti-beta-endorphin antibody-injected rats was still present after substitution with a lower dose of cocaine."( A critical role for beta-endorphin in cocaine-seeking behavior.
Roth-Deri, I; Schindler, CJ; Yadid, G, 2004
)
" Fasting plasma glucose, A1C, HOMA-IR for insulin resistance, lipid profile, and plasma beta-endorphin-like immunoreactivity (BER) were measured before treatment and weekly at the end of each dosing period."( Metformin increases insulin sensitivity and plasma beta-endorphin in human subjects.
Cheng, JT; Ou, HY; Wu, TJ; Yu, EH, 2006
)
" The dosage of Midazolam used for conscious-sedation and the scores of VAS and VSS were also considerably lower in EA group than those in control group (P<0."( [Effects of electroacupuncture on bispectral index and plasma beta-endorphin in patients undergoing colonoscopy].
Chen, Y; Jiang, SH; Li, J; Lian, QQ; Ni, YF; Wang, BF; Zhang, WF, 2009
)
" The drugs were given to the patients continuously intravenously with an injection pump in an even rate, with the dosage adjusted to reach the sedative target of visual analog score (VAS)< or =3-4 and Ramsay 2-4."( [The effects of the plasma levels of serotonin and neuropeptide on ventilated patients with Yitongshu acupuncture points injection].
Deng, ZT; Feng, ZS; Jiang, YY; Jin, JL; Ye, XL; Yin, HY; Zhang, M; Zhang, R, 2010
)
" Dose-response curves showed that the limits of detection of the protein G-multiplexed immunoassays for the PRMMs was approximately 164, 167, 120, 60, 80, and 92 pg/ml, respectively."( A fast universal immobilization of immunoglobulin G at 4 °C for the development of array-based immunoassays.
Chen, CS; Chen, MS; Chen, PC; Cheng, YC; Guo, SL; Lee, HC; Lin, JM, 2012
)
" The findings can contribute to the development of dosage guideline for LLLT for treating MTrP-induced pain."( Fluence-dependent effects of low-level laser therapy in myofascial trigger spots on modulation of biochemicals associated with pain in a rabbit model.
Chou, LW; Hong, CZ; Hsieh, YL; Yang, CC; Yang, SA, 2015
)
"Compared with the control group, the VAS score at 48 h after surgery, and the dosage of the supplemented Sauteralgyl were evidently lower, and the time of both exhaust and defecation after surgery was significantly earlier, and the degree of nausea after surgery was obviously milder in patients of the EA group (P<0."( [Electroacupuncture Intervention Combined with Anesthetics for Analgesia and Post-surgical Gastrointestinal Recovery in Pneumectomy Patients].
Chen, TY; Ma, W; Wang, K; Wu, YY; Xu, JJ; Zhou, J, 2015
)
"EA intervention combined with anesthetics is effective in reducing the dosage of the supplemented Sauteralgyl and the degree of postoperative nausea, and in improving postoperative gastrointestinal functional recovery in patients undergoing pneumectomy."( [Electroacupuncture Intervention Combined with Anesthetics for Analgesia and Post-surgical Gastrointestinal Recovery in Pneumectomy Patients].
Chen, TY; Ma, W; Wang, K; Wu, YY; Xu, JJ; Zhou, J, 2015
)
" Seventy-two Specific pathogen-free (SPF) male Kunming mice were randomly divided into six groups: normal group, positive control group, AEPH of low dosage (100mg/kg) group, AEPH of medium dose (200mg/kg) group, AEPH of high dosage (400mg/kg) group and model group."( Effects of aqueous extracts from Panax ginseng and Hippophae rhamnoides on acute alcohol intoxication: An experimental study using mouse model.
Gong, XY; Hu, XY; Jia, LY; Lin, W; Luo, JX; Wang, YY; Wen, DC, 2016
)
"①The total dosage of sufentanil in the observation group was less than that in the control group[(1."( [Clinical research of electroacupuncture on the analgesic effect of thoracic perioperative stage].
Chang, J; Dong, X; Han, X; Li, Y; Wang, Y; Xing, Q; Zhou, M, 2017
)
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (2)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
regulator of G-protein signaling 4Homo sapiens (human)Potency0.01680.531815.435837.6858AID504845
histone acetyltransferase KAT2A isoform 1Homo sapiens (human)Potency28.18380.251215.843239.8107AID504327
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (21)

Assay IDTitleYearJournalArticle
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1346361Human delta receptor (Opioid receptors)1998NIDA research monograph, Mar, Volume: 178Standard binding and functional assays related to medications development division testing for potential cocaine and opiate narcotic treatment medications.
AID1346329Human kappa receptor (Opioid receptors)1998NIDA research monograph, Mar, Volume: 178Standard binding and functional assays related to medications development division testing for potential cocaine and opiate narcotic treatment medications.
AID1346329Human kappa receptor (Opioid receptors)1995Proceedings of the National Academy of Sciences of the United States of America, Jul-18, Volume: 92, Issue:15
kappa-Opioid receptor in humans: cDNA and genomic cloning, chromosomal assignment, functional expression, pharmacology, and expression pattern in the central nervous system.
AID1346373Mouse delta receptor (Opioid receptors)1994Molecular pharmacology, Feb, Volume: 45, Issue:2
Pharmacological characterization of the cloned kappa-, delta-, and mu-opioid receptors.
AID1346341Mouse kappa receptor (Opioid receptors)1993Proceedings of the National Academy of Sciences of the United States of America, Jul-15, Volume: 90, Issue:14
Cloning and functional comparison of kappa and delta opioid receptors from mouse brain.
AID1346411Rat kappa receptor (Opioid receptors)1993Proceedings of the National Academy of Sciences of the United States of America, Nov-01, Volume: 90, Issue:21
Cloning and pharmacological characterization of a rat kappa opioid receptor.
AID1346400Rat mu receptor (Opioid receptors)1994Molecular pharmacology, Feb, Volume: 45, Issue:2
Pharmacological characterization of the cloned kappa-, delta-, and mu-opioid receptors.
AID1133752Analgesic activity in icv dosed ICR mouse assessed as inhibition of heat stimulus-induced tail flick response measured for 30 to 60 mins1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133755Analgesic activity in ICR mouse assessed as inhibition of acetic acid-induced writhing response at 0.38 ug, icv administered 5 mins prior to acetic acid challenge measured for 15 mins1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133758Analgesic activity in opiate antagonist naloxone hydrochloride-treated ICR mouse assessed as inhibition of heat stimulus-induced tail flick response at 20.1 mg/kg, iv measured for 20 to 30 mins1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133762Potency index, ratio of morphine AD50 to compound AD50 for analgesic activity in icv dosed ICR mouse assessed as inhibition of heat stimulus-induced tail flick response1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133763Potency index, ratio of morphine AD50 to compound AD50 for analgesic activity in ICR mouse assessed as inhibition of thermal stimulus-induced response by hot-plate test1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133764Potency index, ratio of morphine AD50 to compound AD50 for analgesic activity in icv dosed ICR mouse assessed as inhibition of acetic acid-induced writhing response1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133767Analgesic activity in icv dosed ICR mouse assessed as inhibition of thermal stimulus-induced response by hot-plate test1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133753Analgesic activity in ICR mouse assessed as inhibition of heat stimulus-induced tail flick response at 0.38 ug, icv administered opiate antagonist naloxone at 10 mins post compound treatment measured for 30 to 60 mins1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133756Analgesic activity in opiate antagonist naloxone-treated ICR mouse assessed as inhibition of acetic acid-induced writhing response at 0.38 ug, icv administered 5 mins prior to acetic acid challenge measured for 15 mins1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133754Analgesic activity in icv dosed ICR mouse assessed as inhibition of thermal stimulus-induced response by hot-plate test in presence of opiate antagonist naloxone1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133757Analgesic activity in iv dosed ICR mouse assessed as inhibition of heat stimulus-induced tail flick response measured for 20 to 30 mins1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
AID1133766Potency index, ratio of morphine AD50 to compound AD50 for analgesic activity in iv dosed ICR mouse assessed as inhibition of heat stimulus-induced tail flick response1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
Synthesis and analgesic activity of human beta-endorphin.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (6,014)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902744 (45.63)18.7374
1990's1981 (32.94)18.2507
2000's790 (13.14)29.6817
2010's412 (6.85)24.3611
2020's87 (1.45)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 (%)
Trials409 (6.31%)5.53%
Reviews330 (5.09%)6.00%
Case Studies51 (0.79%)4.05%
Observational6 (0.09%)0.25%
Other5,684 (87.72%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (44)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Transesophageal Echocardiography (TEE) and Dysphagia in Lung Transplantation (LT)[NCT06089434]116 participants (Anticipated)Interventional2023-11-30Not yet recruiting
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-brain-stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking[NCT00983450]Phase 220 participants (Anticipated)Interventional2009-10-31Not yet recruiting
DeFect cLOsure After Colonic ESD With underwaTer Technique Versus Conventional Clip : a Randomized Controlled Trial[NCT04214678]64 participants (Actual)Interventional2020-07-01Completed
Decreasing the Incidence of Post-partum Type II Diabetes Mellitus in Gestational Diabetes Population- Prospective Randomized Controlled Trial[NCT05202002]200 participants (Anticipated)Interventional2021-03-01Recruiting
Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)[NCT01367964]28 participants (Anticipated)Interventional2011-07-31Active, not recruiting
Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Healthy Children and Adolescent[NCT03709381]Early Phase 110 participants (Actual)Interventional2017-10-01Completed
Feasibility of a New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection: a Prospective Randomized Controlled Study[NCT05042947]56 participants (Anticipated)Interventional2021-10-01Recruiting
Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)[NCT03330860]150 participants (Actual)Interventional2015-11-16Completed
Acthar for Treatment of Post-transplant FSGS[NCT02399462]Phase 40 participants (Actual)Interventional2021-03-31Withdrawn(stopped due to Funding terminated prematurely)
Staple Versus Suture Closure for Foot and Ankle Surgery[NCT03522753]0 participants (Actual)Interventional2018-09-01Withdrawn(stopped due to Resolving database issues)
Y a T-il Une désensibilisation Pendant le Sommeil après la réception de Violence Verbale ?[NCT03074578]32 participants (Anticipated)Interventional2016-11-08Recruiting
ACTHAR GEL for Sarcoidosis-Associated Calcium Dysregulation: An Open-label Pilot Study[NCT02155803]Phase 2/Phase 310 participants (Anticipated)Interventional2015-02-28Not yet recruiting
Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients[NCT03727776]Early Phase 111 participants (Actual)Interventional2019-08-19Completed
Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study[NCT05126511]40 participants (Actual)Interventional2021-11-19Completed
Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism The ADOPA Randomized Clinical Trial[NCT04461535]228 participants (Actual)Interventional2020-07-08Completed
Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.[NCT02765022]235 participants (Actual)Interventional2016-05-31Completed
An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, Tolerability and Bioactivity of Subcutaneous ACTH GeL in PAtients With Scleritis: The ATLAS Study[NCT03465111]Phase 230 participants (Anticipated)Interventional2019-01-01Recruiting
"Safety and Efficacy of Acthar Gel on Albuminuria and Urinary Transforming Growth Factor Excretion in Type I or Type II Diabetics Requiring Medical Treatment of Hyperglycemia With Nephrotic Range Proteinuria: A Pilot Study"[NCT01028287]Phase 415 participants (Actual)Interventional2009-05-31Completed
Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy[NCT01921374]60 participants (Actual)Interventional2013-08-31Completed
The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies[NCT04398537]245 participants (Actual)Interventional2020-08-03Completed
Double-blind, Randomized Controlled Study to Assess the Analgesic Effect of a Single Intravenous Dose of 2 g of Magnesium Dipyrone (Metamizol) and Changes in Plasma Beta-endorphin Immunoreactivity (Beta-EPIr) Values in Patients Undergoing Elective Inguina[NCT04595877]Phase 460 participants (Actual)Interventional2006-01-31Completed
Minimally Invasive Urologic Surgery Clip Evaluation: Can We Improve Our Surgical Technique, Reduce Costs and Waste With the Aesculap U-clip Versus the Tele-Flex Hemolock Clip?[NCT01008709]11 participants (Actual)Interventional2009-10-31Terminated(stopped due to poor enrollment)
Availability and Safety Study of ACTH to Treat Children SRNS/SDNS[NCT02972346]42 participants (Anticipated)Interventional2016-11-30Recruiting
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy : a Prospective Randomized Control Trial.[NCT05838001]110 participants (Anticipated)Interventional2023-02-16Recruiting
Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis[NCT02030028]18 participants (Actual)Interventional2014-11-30Completed
The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis[NCT01428336]22 participants (Actual)Interventional2011-09-30Completed
Functional Benefit With ACRYSOF® Natural Chromophore[NCT02219997]90 participants (Actual)Interventional2014-10-31Completed
Adrenocorticotropic Hormone (ACTH) for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome[NCT02132195]Phase 331 participants (Actual)Interventional2014-05-31Completed
The Influence of Different Mood States and Emotions on the Physiologic, Metabolic, and Perceptual Responses to Feeding Before Exercise[NCT05217589]90 participants (Anticipated)Interventional2022-04-01Recruiting
Effect of Blue Light Filtration on Visual Performance[NCT01938989]158 participants (Actual)Interventional2013-09-30Completed
Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone[NCT04808856]60 participants (Anticipated)Interventional2021-04-01Recruiting
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar[NCT02546492]Phase 46 participants (Actual)Interventional2016-08-31Terminated(stopped due to Slow Enrollment)
[NCT00004496]Phase 145 participants (Anticipated)Interventional1999-02-28Completed
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients[NCT02057523]Phase 42 participants (Actual)Interventional2014-09-30Terminated(stopped due to Unable to enroll patients, no longer at institution.)
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome[NCT00989781]41 participants (Actual)Interventional2009-09-30Completed
Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy[NCT02941640]120 participants (Actual)Interventional2016-10-02Completed
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery[NCT01839812]Phase 135 participants (Actual)Interventional2009-03-31Completed
Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping[NCT01647581]11,182 participants (Actual)Interventional2011-09-01Completed
Feasibility Study of Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node After Neoadjuvant Systemic Therapy for Clinically Assessed Positive Axillary Lymph Node (cN+) Breast Cancer[NCT04482803]159 participants (Actual)Interventional2020-09-24Completed
Clinical Evaluation of Spring-Type Laparoscopic Clip Technology[NCT00527644]14 participants (Actual)Interventional2007-07-31Terminated(stopped due to Insufficient funding to complete study)
The Adrenal Contribution to Androgen Production in Girls During Puberty[NCT01062568]Phase 350 participants (Actual)Interventional2010-02-28Completed
Effects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple Sclerosis[NCT02290444]Phase 364 participants (Actual)Interventional2013-08-31Completed
Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS[NCT02446886]Phase 415 participants (Actual)Interventional2016-06-30Terminated(stopped due to Slow enrollment)
Open Label Proof of Concept Study to Evaluate Efficacy and Safety of Adrenocorticotropic Hormone Gel in Refractory Dermatomyositis or Polymyositis[NCT01906372]Phase 212 participants (Actual)Interventional2013-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00527644 (1) [back to overview]No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.
NCT00989781 (5) [back to overview]Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
NCT00989781 (5) [back to overview]Anti-Mullerian Hormone (AMH)
NCT00989781 (5) [back to overview]Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls
NCT00989781 (5) [back to overview]17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
NCT00989781 (5) [back to overview]17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
NCT01062568 (3) [back to overview]Free Testosterone Response to ACTH
NCT01062568 (3) [back to overview]Androstenedione Response to ACTH
NCT01062568 (3) [back to overview]17-hydroxyprogesterone Response to ACTH
NCT01428336 (3) [back to overview]Peak Total Cortisol Values
NCT01428336 (3) [back to overview]Pearson Correlation of Free Cortisol Values During CSTs With ITT
NCT01428336 (3) [back to overview]Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs
NCT01647581 (1) [back to overview]Number of Patients With Delayed Post Polypectomy Bleeding
NCT01906372 (2) [back to overview]Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.
NCT01906372 (2) [back to overview]Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).
NCT01938989 (1) [back to overview]Photostress Recovery Time
NCT02030028 (5) [back to overview]Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
NCT02030028 (5) [back to overview]Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
NCT02030028 (5) [back to overview]Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
NCT02030028 (5) [back to overview]Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
NCT02030028 (5) [back to overview]Patient Reported Changes in Fatigue Between Week 0 and Week 12
NCT02057523 (2) [back to overview]25% Improvement in the MDRD eGFR
NCT02057523 (2) [back to overview]50% Reduction in Proteinuria or Proteinuria < 150mg/Day
NCT02132195 (3) [back to overview]Number of Adverse Events
NCT02132195 (3) [back to overview]Number of Participants Experienced a Relapse of Nephrotic Syndrome
NCT02132195 (3) [back to overview]Number of Participants Experiencing Relapses After Dose Reduction of ACTH
NCT02219997 (3) [back to overview]Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
NCT02219997 (3) [back to overview]Change in Braking Reaction Time From No-glare to Glare
NCT02219997 (3) [back to overview]Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)
NCT02290444 (9) [back to overview]Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
NCT02290444 (9) [back to overview]Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
NCT02290444 (9) [back to overview]Change From Baseline on the Expanded Disability Status Scale (EDSS).
NCT02290444 (9) [back to overview]Change From Baseline on the Fatigue Severity Scale (FSS)
NCT02290444 (9) [back to overview]Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
NCT02290444 (9) [back to overview]Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)
NCT02290444 (9) [back to overview]Change From Baseline on the Symbol Digit Modalities Test (SDMT)
NCT02290444 (9) [back to overview]Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
NCT02290444 (9) [back to overview]Timed 25-foot Walk
NCT02446886 (4) [back to overview]Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months
NCT02446886 (4) [back to overview]Change in T2 Lesion Volume
NCT02446886 (4) [back to overview]Longitudinal Assessment of MWF
NCT02446886 (4) [back to overview]Physical Disability as Measured by EDSS
NCT02546492 (2) [back to overview]Efficacy Outcome
NCT02546492 (2) [back to overview]Safety (Serious Adverse Events)
NCT02941640 (6) [back to overview]Intra-perative Complications
NCT02941640 (6) [back to overview]Operative Time
NCT02941640 (6) [back to overview]Overall Morbidity
NCT02941640 (6) [back to overview]Postoperative Complications
NCT02941640 (6) [back to overview]Time of Application
NCT02941640 (6) [back to overview]Hospital Stay
NCT04398537 (4) [back to overview]Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
NCT04398537 (4) [back to overview]Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
NCT04398537 (4) [back to overview]Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
NCT04398537 (4) [back to overview]Average Distance of Clip Migration for the Arm That Received 5mm Retraction.

No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.

(NCT00527644)
Timeframe: By post op day one HIDA scan.

InterventionParticipants (Count of Participants)
Spring Clips14

[back to top]

Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls

17-hydroxyprogesterone response to ACTH infusion in women with PCOS and normal women. Response is reported as a single value generated by summing the data at end time frame. (NCT00989781)
Timeframe: Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH

Interventionng/ml (Mean)
NR-PCOS Women6.0
HR-PCOS Women8.1
Normal Women6.2

[back to top]

Anti-Mullerian Hormone (AMH)

(NCT00989781)
Timeframe: Baseline

Interventionng/ml (Mean)
NR-PCOS Women16.0
HR-PCOS Women6.7
Normal Women5.3

[back to top]

Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls

3-D ultrasound was not assessed; instead 2-D ultrasound was performed (NCT00989781)
Timeframe: baseline

InterventionAntral Follicle Count (Mean)
NR-PCOS Women64.4
HR-PCOS Women49.3
Normal Women31.8

[back to top]

17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.

17 hydroxyprogesterone levels (NCT00989781)
Timeframe: Baseline and 24 after hCG

InterventionParticipants (Count of Participants)
NR-PCOS Women0
HR-PCOS Women0
Normal Women0

[back to top]

17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls

Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection (NCT00989781)
Timeframe: Baseline and 24 hours after hCG

Interventionng/ml (Mean)
NR-PCOS Women1.3
HR-PCOS Women3
Normal Women1.1

[back to top]

Free Testosterone Response to ACTH

Free Testosteorne levels before and after ACTH (NCT01062568)
Timeframe: 0 and 60 min after ACTH administration

,
Interventionpmol/L (Mean)
Normal weightOverweight
Early Puberty Group23.5
Late Puberty Group732

[back to top]

Androstenedione Response to ACTH

Androstenedione levels before and after ACTH (NCT01062568)
Timeframe: 0 and 60 min after ACTH administration

,
Interventionng/mL (Mean)
Normal WieghtOverweight
Early Puberty0.50.6
Late Puberty1.63.1

[back to top]

17-hydroxyprogesterone Response to ACTH

17-hyrooxyprogesterone levels before and after ACTH (NCT01062568)
Timeframe: 0 and 60 minutes after ACTH administration

,,
Interventionng/mL (Mean)
Normal WeightOver Weight
Early Puberty Group2.42.9
Late Puberty Group3.73.1
Total Number3.13.0

[back to top]

Peak Total Cortisol Values

Peak total cortisol values during cortrosyn stimulation tests(CST) (NCT01428336)
Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions

,
Interventionug/dl (Median)
Insulin Tolerance Test1 ug ACTH stimulation test25 ug ACTH stimulation test30 min 250 ug ACTH stimulation test60 min 250 ug ACTH simulation test
Patients23.323.422.022.325.0
Volunteers16.614.517.416.119.1

[back to top]

Pearson Correlation of Free Cortisol Values During CSTs With ITT

Correlation of free cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table (NCT01428336)
Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions

Interventioncorrelation coefficient (Number)
Peak 1ug ACTH stimulation testPeak 25ug ACTH stimulation test60- minute 250ug ACTH stimulation test30-minute 250ug ACTH stimulation test
Patients + Volunteers0.580.700.880.89

[back to top]

Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs

Correlation of total cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table (NCT01428336)
Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions

Interventioncorrelation coefficient (Number)
Peak 1 ug ACTH stimulation testPeak 25 ug ACTH stimultion test60-minute 250ug ACTH stimulation test30-minute 250ug ACTH stimulation test
Patients + Volunteers0.80.860.930.92

[back to top]

Number of Patients With Delayed Post Polypectomy Bleeding

rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery (NCT01647581)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Clip12
No Clip15

[back to top]

Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.

Mean change in glucocorticoid dose (equivalent prednisone dose) at 24 weeks compared to baseline. (NCT01906372)
Timeframe: Steroid sparing effect and safety and tolerability at 24 weeks compared to baseline

Interventionmg (Mean)
Follow Up 24 weeksBaseline
Acthar Gel2.318.5

[back to top]

Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).

3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the MMT). The DOI should be met at least once on any of the 6 follow up visits and maintained until week 24. Subjects not meeting DOI during the trial are treatment failures. (NCT01906372)
Timeframe: Primary end point: IMACS preliminary definition of improvement (DOI)

InterventionParticipants (Count of Participants)
Acthar Gel7

[back to top]

Photostress Recovery Time

Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed. (NCT01938989)
Timeframe: Day 1

Interventionseconds (Mean)
Blue Light Filter5.66
Clear6.94

[back to top]

Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12

Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP < 0)) (NCT02030028)
Timeframe: 12 weeks

Interventionmg/dl (Mean)
ACTHAR Gel0.36

[back to top]

Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12

Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS < 0) (NCT02030028)
Timeframe: 12 weeks

Interventionmm/hr (Mean)
ACTHAR Gel-7.38

[back to top]

Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12

"Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement.~Scale: 0-8.61 (lower scores indicate reduced disease activity)" (NCT02030028)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
ACTHAR Gel-0.87

[back to top]

Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12

percentage of participants achieving >20% improvement in CDAI after 12 weeks of therapy (>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 < 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity) (NCT02030028)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
ACTHAR Gel8

[back to top]

Patient Reported Changes in Fatigue Between Week 0 and Week 12

The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue. (NCT02030028)
Timeframe: 12 weeks

Interventionunits on a scale (Median)
ACTHAR Gel-3.8

[back to top]

25% Improvement in the MDRD eGFR

(NCT02057523)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Acthar1

[back to top]

50% Reduction in Proteinuria or Proteinuria < 150mg/Day

(NCT02057523)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Acthar1

[back to top]

Number of Adverse Events

Adverse events will be collected (SAEs and AEs) (NCT02132195)
Timeframe: 12 months

Interventionnumber of events (Number)
Adrenocorticotropic Hormone (ACTH)12
No Treatment4
Rescue Therapy17

[back to top]

Number of Participants Experienced a Relapse of Nephrotic Syndrome

Number of participants experienced a relapse of nephrotic syndrome during the initial 6 months of the study. (NCT02132195)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Adrenocorticotropic Hormone (ACTH)14
No Treatment15

[back to top]

Number of Participants Experiencing Relapses After Dose Reduction of ACTH

The dose of ACTH will be reduced by 50% after 6 months and the rate of relapse during this period will be evaluated. (NCT02132195)
Timeframe: 6 to 12 months

InterventionParticipants (Count of Participants)
Adrenocorticotropic Hormone (ACTH)0
Rescue Therapy0

[back to top]

Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)

Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only. (NCT02219997)
Timeframe: Visit 2, Up to Day 30

Interventionseconds (Mean)
Placebo Filter0.17
Blue Light Filter0.16

[back to top]

Change in Braking Reaction Time From No-glare to Glare

Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. (NCT02219997)
Timeframe: Visit 2, up to Day 30

Interventionseconds (Mean)
AcrySof IQ IOL0.07
Clear IOL0.15

[back to top]

Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)

Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. (NCT02219997)
Timeframe: Visit 2, Up to Day 30

Interventionseconds (Mean)
ACRYSOF IQ IOL + Placebo Filter0.12
Clear IOL + BLF0.16

[back to top]

Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)

A self-report, multiple choice inventory of depression. Minimum of 0, maximum of 21. Higher score indicates higher levels of depression. The difference in total score on the BDI-FS from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Score (Mean)
Cognitively Relapsing Patients5.0
Stable Multiple Sclerosis Patients1.6

[back to top]

Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)

A measure of visual/spatial memory. Minimum of 0, maximum of 36. Higher score indicates better performance. The difference in total learning score on the BVMT-R from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Learning Score (Mean)
Cognitively Relapsing Patients22.0
Stable Multiple Sclerosis Patients22.5

[back to top]

Change From Baseline on the Expanded Disability Status Scale (EDSS).

A clinician assigned measure of disability specific to MS. Minimum of 0 (no disability), maximum of 10 (death due to MS). Higher scores indicate greater disability. The difference in total score on the EDSS from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Score (Median)
Cognitively Relapsing Patients3.0
Stable Multiple Sclerosis Patients2.0

[back to top]

Change From Baseline on the Fatigue Severity Scale (FSS)

A self-report measure of fatigue. 1 (no fatigue) to 9 (severe fatigue). The difference in total score on FSS from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Score (Mean)
Cognitively Relapsing Patients5.4
Stable Multiple Sclerosis Patients3.8

[back to top]

Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)

A self and informant rating measure of perceived cognitive problems. Minimum of 0, maximum of 60. Higher scores indicates greater self-reported neuropsychological impairment. The difference in total score on the MSNQ from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Score (Mean)
Cognitively Relapsing Patients34.5
Stable Multiple Sclerosis Patients20.0

[back to top]

Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)

A measure of auditory processing speed and working memory. Minimum value of 0, maximum value of 60. Higher score indicates better performance. The difference in total correct on the PASAT from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Correct (Mean)
Cognitively Relapsing Patients40.1
Stable Multiple Sclerosis Patients47.0

[back to top]

Change From Baseline on the Symbol Digit Modalities Test (SDMT)

A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. The difference in total correct responses on the SDMT from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Correct (Mean)
Cognitively Relapsing Patients44.6
Stable Multiple Sclerosis Patients58.5

[back to top]

Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)

A measure of auditory/verbal episodic memory. Minimum of 0, maximum of 80. Higher score indicates better performance. The difference in total learning score on the CVLT-II from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionTotal Learning Score (Mean)
Cognitively Relapsing Patients46.6
Stable Multiple Sclerosis Patients51.2

[back to top]

Timed 25-foot Walk

An MS-specific measure of functional status walking speed. How many seconds does it take to walk 25 feet. Ceiling value of 300 seconds. (NCT02290444)
Timeframe: Day 0 and Day 90

InterventionSeconds (Mean)
Cognitively Relapsing Patients6.7
Stable Multiple Sclerosis Patients5.3

[back to top]

Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months

"Primary outcome: The absolute change in lesion MWF (over our test-retest variability) between baseline and one year MRI's will be calculated and compared between treatment groups.~Method to assess lesion MWF: FAST-T2 is a multi-compartment T2 relaxometry MRI technique wherein the contribution of water associated with myelin and other tissue compartments is differentiated using T2 decay curve analysis. The relative contribution of the myelin water with respect to total water is represented as MWF. A higher MWF within a lesion reflects higher myelin content within that lesion.~For this analysis, MWF maps were reconstructed from FAST-T2 MRI data by using a multi-voxel nonlinear least-squares data-fitting algorithm with spatial smoothness constraints. MWF was calculated as the ratio of the myelin water signal to the total water signal within a voxel. Lesion MWF is an average of the voxels present within an individual lesion." (NCT02446886)
Timeframe: Baseline, 12 months

Interventionmyelin water fraction (Mean)
One Time Treatment1.7
Monthly Treatments-0.20

[back to top]

Change in T2 Lesion Volume

The change in T2 lesion volume between baseline and one year MRI's will be calculated and compared between treatment groups. (NCT02446886)
Timeframe: 12 months

Interventionmillimeters cubed (Mean)
One Time Treatment683.59
Monthly Treatments1092.08

[back to top]

Longitudinal Assessment of MWF

"Outcome measure: Longitudinal assessment of MWF (every 3 months) to determine the dynamics of myelin change over 12 months.~Method to assess lesion MWF: FAST-T2 is a multi-compartment T2 relaxometry MRI technique wherein the contribution of water associated with myelin and other tissue compartments is differentiated using T2 decay curve analysis. The relative contribution of the myelin water with respect to total water is represented as MWF. A higher MWF within a lesion reflects higher myelin content within that lesion.~For this analysis, MWF maps were reconstructed from FAST-T2 MRI data by using a multi-voxel nonlinear least-squares data-fitting algorithm with spatial smoothness constraints. MWF was calculated as the ratio of the myelin water signal to the total water signal within a voxel. Lesion MWF is an average of the voxels present within an individual lesion." (NCT02446886)
Timeframe: 12 months

Interventionmyelin water fraction (Mean)
One Time Treatment1.7
Monthly Treatments-.2

[back to top]

Physical Disability as Measured by EDSS

"Expanded Disability Status Scale (EDSS)~0 Normal neurological exam, no disability in any FS 1.0 No disability, minimal signs in one FS 1.5 No disability, minimal signs in more than one FS 2.0 Minimal disability in one FS 2.5 Mild disability in one FS or minimal disability in two FS 3.0 Moderate disability in one FS, or mild disability in three or four FS. No impairment to walking 3.5 Moderate disability in one FS and more than minimal disability in several others. No impairment to walking 4.0 Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5 Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m~10.0 Death due to MS~A higher score means a worse outcome." (NCT02446886)
Timeframe: 12 months

Interventionscore on a scale (Mean)
One Time Treatment.5
Monthly Treatments1.1

[back to top]

Efficacy Outcome

composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria (NCT02546492)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Composite outcomeDeathDecreased GFR>10%Increased proteinuria
Efficacy Outcomes3111

[back to top]

Safety (Serious Adverse Events)

"Participants will be monitored for Serious Adverse Events, as follows (as described in ClinicalTrials.gov) Death, Life-threatening events, Hospitalization (initial or prolonged), Disability and events that requires intervention to prevent permanent impairment or damage.~Other (non serious) events which were anticipated or unanticipated (as described in ClinicaTrials.gov) will be monitored.~ASSESSMENT: The subjects will be assessed at regular intervals through a questionnaire for Acthar related events, physician evaluation at clinical visits, and self reporting." (NCT02546492)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Serious Adverse Events (SAE)2

[back to top]

Intra-perative Complications

Complications that appear during operative procedure (NCT02941640)
Timeframe: 120 min.

InterventionParticipants (Count of Participants)
Laparoscopic Appendectomy. Endoloop.0
Laparoscopic Appendectomy. Stapler0
Laparoscopic Appendectomy. Hem-o-lok Clip0
Laparoscopic Appendectomy. DS Clip0

[back to top]

Operative Time

Time of operative procedure (NCT02941640)
Timeframe: 120 min.

Interventionminutes (Mean)
Laparoscopic Appendectomy. Endoloop.46.0
Laparoscopic Appendectomy. Stapler39.37
Laparoscopic Appendectomy. Hem-o-lok Clip42.83
Laparoscopic Appendectomy. DS Clip47.47

[back to top]

Overall Morbidity

Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day. (NCT02941640)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Laparoscopic Appendectomy. Endoloop.0
Laparoscopic Appendectomy. Stapler0
Laparoscopic Appendectomy. Hem-o-lok Clip0
Laparoscopic Appendectomy. DS Clip0

[back to top]

Postoperative Complications

Complications that appear after operative procedure (NCT02941640)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Laparoscopic Appendectomy. Endoloop.0
Laparoscopic Appendectomy. Stapler0
Laparoscopic Appendectomy. Hem-o-lok Clip0
Laparoscopic Appendectomy. DS Clip0

[back to top]

Time of Application

Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix (NCT02941640)
Timeframe: 120 min

Interventionseconds (Mean)
Laparoscopic Appendectomy. Endoloop.195.50
Laparoscopic Appendectomy. Stapler19.87
Laparoscopic Appendectomy. Hem-o-lok Clip63.90
Laparoscopic Appendectomy. DS Clip63.77

[back to top]

Hospital Stay

Length of hospitalization (NCT02941640)
Timeframe: 30 days

Interventiondays (Median)
Laparoscopic Appendectomy. Endoloop.2.17
Laparoscopic Appendectomy. Stapler2.20
Laparoscopic Appendectomy. Hem-o-lok Clip2.23
Laparoscopic Appendectomy. DS Clip2.37

[back to top]

Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.

(NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)

Interventionmm (Mean)
no Retraction of Clip Deployment Apparatus9.8

[back to top]

Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.

(NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)

InterventionParticipants (Count of Participants)
5mm Retraction of Clip Deployment Apparatus46
no Retraction of Clip Deployment Apparatus44

[back to top]

Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.

This number of participants will be counted if their clip migrated more than 10mm from the biopsy site. (NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)

InterventionParticipants (Count of Participants)
5mm Retraction of Clip Deployment Apparatus46
no Retraction of Clip Deployment Apparatus44

[back to top]

Average Distance of Clip Migration for the Arm That Received 5mm Retraction.

(NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)

Interventionmm (Mean)
5mm Retraction of Clip Deployment Apparatus12.1

[back to top]