Page last updated: 2024-11-12

cosyntropin

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Description

Cosyntropin: A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of ADRENOCORTICOTROPIC HORMONE. ACTH (1-24), a segment similar in all species, contains the biological activity that stimulates production of CORTICOSTEROIDS in the ADRENAL CORTEX. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

cosyntropin : A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of adrenocorticotropic hormone (corticotropin). A segment similar in all species, it contains the biological activity that stimulates production of corticosteroids in the adrenal cortex. It is used diagnostically to investigate adrenocortical insufficiency. [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 CID16129617
SCHEMBL ID720535
MeSH IDM0005246

Synonyms (15)

Synonym
cortrosyn
tetracosapeptide
tetracosactide acetate
cortrosinta
actholain
tetracosactid
cosyntropin
tetracosactrin
tetracosactide
16960-16-0
cortrosyn (tn)
D00284
cosyntropin (usp)
gtpl6965
SCHEMBL720535

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"Intranasal mometasone furoate (MF) has been extensively studied in adults and has been found to be safe and effective therapy for the treatment of allergic rhinitis."( Safety and efficacy of mometasone furoate aqueous nasal spray in children with allergic rhinitis: results of recent clinical trials.
Dibildox, J, 2001
)
0.31
"A retrospective study of 135 patients receiving ACTH therapy with a synthetic analogue for initial effect, seizure outcome 1 year after therapy, and adverse effects."( Therapeutic efficacy and adverse effects of adrenocorticotropic hormone therapy in west syndrome: differences in dosage of adrenocorticotropic hormone, onset of age, and cause.
Eto, Y; Hamano, S; Minamitani, M; Tanaka, M; Yamashita, S; Yoshinari, S, 2006
)
0.33
" Adverse effects were observed in 57, and ACTH therapy was discontinued in 23."( Therapeutic efficacy and adverse effects of adrenocorticotropic hormone therapy in west syndrome: differences in dosage of adrenocorticotropic hormone, onset of age, and cause.
Eto, Y; Hamano, S; Minamitani, M; Tanaka, M; Yamashita, S; Yoshinari, S, 2006
)
0.33
" A total of 94% and 100% of MFNS and BDP subjects, respectively, reported adverse events (AEs), which were mostly mild or moderate."( Mometasone furoate nasal spray is safe and effective for 1-year treatment of children with perennial allergic rhinitis.
Meltzer, EO; Ratner, PH; Teper, A, 2009
)
0.35

Pharmacokinetics

ExcerptReferenceRelevance
" Pharmacokinetic parameters of prednisolone as assessed by Cmax, t 1/2, AUC, or serum protein binding were not affected by prasterone."( Effects of oral prasterone (dehydroepiandrosterone) on single-dose pharmacokinetics of oral prednisone and cortisol suppression in normal women.
Blum, RA; Jusko, WJ; Meno-Tetang, GM; Schwartz, KE, 2001
)
0.31
" In this study, the validity of these strategies was verified by investigating the plasma pharmacokinetic and urinary excretion profiles of relevant glucocorticoids in bovines, subjected to exogenous prednisolone treatment or tetracosactide hexaacetate administration to induce endogenous prednisolone formation."( Pharmacokinetic and urinary profiling reveals the prednisolone/cortisol ratio as a valid biomarker for prednisolone administration.
Croubels, S; De Clercq, N; Delahaut, P; Devreese, M; Fichant, E; Van Meulebroek, L; Vanden Bussche, J; Vanhaecke, L, 2017
)
0.46
"We conducted 5 studies: 4 open-label, sequence-randomized, crossover, pharmacodynamic studies testing 6 doses/formulations and a repeatability study."( Pharmacodynamic studies of nasal tetracosactide with salivary glucocorticoids for a noninvasive Short Synacthen Test.
Cross, AS; Elder, CJ; Johnson, TN; Keevil, BG; Kemp, EH; Ross, RJ; Taylor, RN; Vilela, R; Wright, NP, 2020
)
0.56

Bioavailability

ExcerptReferenceRelevance
" The effect of formulation additives on tetracosactide bioavailability was studied following modification of nasal saline solution."( Effect of formulation additives upon the intranasal bioavailability of a peptide drug: tetracosactide (ACTH1-24).
Buri, P; Martenet, M; Wüthrich, P, 1994
)
0.29
" The bioavailability of Nasacthin003 was 14."( Pharmacodynamic studies of nasal tetracosactide with salivary glucocorticoids for a noninvasive Short Synacthen Test.
Cross, AS; Elder, CJ; Johnson, TN; Keevil, BG; Kemp, EH; Ross, RJ; Taylor, RN; Vilela, R; Wright, NP, 2020
)
0.56

Dosage Studied

Studies on 1 μg low-dose test showed that some adrenocorticotropic hormone dosage was not recovered, and in healthy volunteers it provided subnormal cortisol responses. LDT would show comparable morning and afternoon cortisol stimulation.

ExcerptRelevanceReference
" Log dose-response curves of the adrenal cells for ACTH and of the pituitary cell-adrenal cell system for CRF were linear over the ranges used."( A superfusion system technique for the study of the sites of action of glucocorticoids in the rat hypothalamus-pituitary-adrenal system in vitro. II. Hypothalamus-pituitary cell-adrenal cell superfusion.
Mulder, GH; Smelik, PG; Vermes, I, 1977
)
0.26
"The addition of phenobarbitone in therapeutic dosage to the drug regimen of prednisolone-treated subjects with rheumatoid arthritis produced measurable deterioration in the clinical status of the patients associated with a more rapid clearance of prednisolone from plasma."( Effects of enzyme induction on metabolism of prednisolone. Clinical and laboratory study.
Brooks, PM; Buchanan, WW; Downie, WW; Grove, M, 1976
)
0.26
" In DRG neurons a bell-shaped dose-response curve was found for alpha-MSH, the maximal effect being observed after 48 h at 100 nM: 54% for B-50/GAP43 and 22% for NF."( Stimulation by melanocortins of neurite outgrowth from spinal and sensory neurons in vitro.
Bär, PR; Gispen, WH; Hol, EM; van der Neut, R,
)
0.13
"The aim of this double blind placebo-controlled cross-over study was to evaluate the effects of fadrozole, a new oral nonsteroidal aromatase inhibitor, on basal and stimulated cortisol and aldosterone secretion at a daily dosage of 4 mg given for 14 days to eight healthy men."( The effects of fadrozole hydrochloride on aldosterone secretion in healthy male subjects.
Aupetit, B; Bhatnagar, AS; Ezzet, F; Girard, F; Menard, J; Mueller, P; Trunet, PF; Zognbi, F, 1992
)
0.28
" The results show a dose-response relationship and the assay seems to be specific for alpha-MSH, because other peptides such as ACTH, beta-LPH and beta-endorphins do not compete for binding sites as alpha-MSH does."( Evidence for alpha-MSH binding sites on human scalp hair follicles: preliminary results.
Bos, JD; Ghanem, GE; Lejeune, FJ; Nanninga, PB; Westerhof, W, 1991
)
0.28
" Overall, the administration of fluticasone propionate once daily in the morning was as effective as the twice daily dosage regimen, and either regimen was more effective than placebo."( Once daily fluticasone propionate aqueous nasal spray is an effective treatment for seasonal allergic rhinitis.
Bronsky, EA; Fireman, P; Grossman, J; LaForce, CF; Lemanske, RF; Nathan, RA; Pearlman, DS; Ratner, PH; Rogenes, PR, 1991
)
0.28
" (1-24) ACTH, given at a dosage of 20 IU/animal, increased C and Aldo-gluc."( Excretion of electrolytes, free cortisol and aldosterone-18-oxo-glucuronide in 24-hr urines of the Mongolian gerbil (Meriones unguiculatus): effect of lysine-vasopressin and adrenocorticotrophin administration, and of changes in sodium balance.
Fenske, M, 1990
)
0.28
" There were no consistent effects of age or sex on any index of adrenocortical sensitivity or responsiveness, but some groups showed isolated differences from both their age- and sex-matched counterparts: the response to 60 ng ACTH was low in young men, maximal responsiveness was low in elderly men and the slope of the dose-response curve was high in elderly women."( Ageing and the sensitivity of the adrenal gland to physiological doses of ACTH in man.
Barton, RN; Horan, MA; Roberts, NA, 1990
)
0.28
" ACTH(1-24) and 8-bromocyclic AMP both provoked a dose-related release of putrescine-derived GABA, although the dose-response curve for the latter differed somewhat from that for the release of corticosterone by this secretogogue."( Formation of releasable gamma-aminobutyrate from putrescine by rat adrenal slices in vitro.
Gillham, B; Oon, BB; Scraggs, PR, 1989
)
0.28
" Despite this return of the basic cortisol secretion, adrenocortical reactivity after a high dosage of ACTH(1-24) was significantly reduced in tethered bulls."( Behavior, episodic secretion of cortisol, and adrenocortical reactivity in bulls subjected to tethering.
Ladewig, J; Smidt, D, 1989
)
0.28
" A curvilinear dose-response relationship to ACTH1-24 was obtained which was similar for each route of administration when expressed in terms of maximum cortisol concentrations."( Effect of dose and route of administration of ACTH1-24 on plasma cortisol concentrations in ewes.
Benhaj, KM; Cooke, RG; Dobson, H; Essawy, SA, 1989
)
0.28
" The dose-response kinetics of the peptides were bell-shaped; maximal responses were reached in both instances at 1 fmol/L to 10 pmol/L."( Immunoglobulins of patients with Cushing's syndrome due to pigmented adrenocortical micronodular dysplasia stimulate in vitro steroidogenesis.
Drexhage, HA; Jeucken, P; Mol, JA; van der Gaag, RD; Wiersinga, WM; Wulffraat, NM, 1988
)
0.27
"05) between responses resulting from the 2 dosage rates."( Plasma endogenous ACTH concentrations and plasma cortisol responses to synthetic ACTH and dexamethasone sodium phosphate in healthy cats.
Feldman, EC; Smith, MC, 1987
)
0.27
" 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
)
0.27
"The time-course and dose-response of the in-vivo secretion of aldosterone and corticosterone after administration of ACTH(1-24) were measured in adrenal venous blood from female Brattleboro rats, homozygous for hypothalamic diabetes insipidus and lacking arginine vasopressin (AVP)."( Release of aldosterone and corticosterone from the adrenal cortex of the Brattleboro rat in response to administration of ACTH.
Brudieux, R; Krifi, MN; Laulin, JP, 1986
)
0.27
" 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
)
0.27
" The median effective concentration (EC50) and the maximal corticosterone response per microgram of DNA of dose-response curves derived from lean and obese rats were not significantly different."( Responsiveness of isolated adrenocortical cells from lean and obese Zucker rats to ACTH.
Davenport, WD; Porter, JR; White, BD, 1988
)
0.27
" Neither the dosage of ACTH1-24 nor the strain of rats influenced the occurrence of SD and the incidence of ACTH-induced grooming behavior."( Electroencephalographic spreading depression and concomitant behavioral changes induced by intrahippocampal injections of ACTH1-24 and D-Ala2-Met-enkephalinamide in the rat.
Huston, JP; Oitzl, MS, 1984
)
0.27
" Biphasic dose-response curves were obtained, comparable to those described for other cytochemical bioassays."( In vitro trophic effects of synthetic ACTH1-24.
Drexhage, HA; Jolink, D; van der Gaag, RD, 1984
)
0.27
" Thus it appears that CA has no untoward effect upon glucocorticoid secretion when given in high dosage for prolonged periods to hirsute women."( Effect of cyproterone acetate on glucocorticoid secretion in patients treated for hirsutism.
Croxson, MS; Evans, MC; France, J; Holdaway, IM; Ibbertson, HK; Sheehan, A; Wilson, T, 1983
)
0.27
"This study compares the effects on the hypothalamo-pituitary adrenal (HPA) axis of two dosage schedules of hydrocortisone 17-butyrate and hydrocortisone ointments in 20 children suffering from eczema."( Study of the effects of hydrocortisone and hydrocortisone 17-butyrate ointments on plasma ACTH levels and Synacthen responses in children with eczema.
Butler, J; Byrne, JP; Keenan, J; Marten, RH; Peiris, S, 1980
)
0.26
"A mammalian isolated adrenal cell system was validated as a bioassay for goldfish ACTH; the log dose-response curve for the goldfish hormone is parallel to that for synthetic mammalian ACTH1-24, and the two ACTHs induce the same maximum rate of corticosterone production."( Preparation of enriched populations of corticotrophs from goldfish rostral pars distalis.
Eastman, JT; Portanova, R, 1983
)
0.27
" A logarithmic dose-response relationship between the dose of ACTH administered and plasma cortisol concentration was found."( Dose response relationship between plasma ACTH and cortisol after the infusion of ACTH1-24.
Carroll, BJ; Helms, MJ; Krishnan, KR; Miller, MN; Nemeroff, CB; Reed, D; Ritchie, JC, 1993
)
0.29
"Little is known about the dose-response relationship of potential, unwanted, effects of inhaled beclomethasone (BDP) on the hypothalamo-pituitary-adrenal (HPA) axis, particularly in nonspecialist clinic settings."( Inhaled beclomethasone dipropionate suppresses the hypothalamo-pituitary-adrenal axis in a dose dependent manner.
Cooke, RR; Durham, JA; Feek, CM; Grebe, SK; Kljakovic, M, 1997
)
0.3
"The efficacy and safety of regular-strength beclomethasone dipropionate MDI prescribed within its recommended dosing range of 2 to 5 puffs three to four times daily has been well established in more than 25 years of worldwide use."( A systemic bioactivity comparison of double-strength and regular-strength beclomethasone dipropionate MDI formulations.
Affrime, MB; Brannan, MD; Herron, JM; Reidenberg, P, 1998
)
0.3
"Beclomethasone dipropionate, administered either via a double-strength (84 microg/puff) or regular-strength (42 microg/puff) inhaler dosed at 840 microg/day showed no evidence of hypothalamic-pituitary-adrenocortical axis suppression in adults with moderate asthma."( A systemic bioactivity comparison of double-strength and regular-strength beclomethasone dipropionate MDI formulations.
Affrime, MB; Brannan, MD; Herron, JM; Reidenberg, P, 1998
)
0.3
" It is concluded that (1) maternal infusion of ACTH1-24 at the dosage used does not induce labour in guinea-pigs, and (2) ACTH1-24 does not cross the placenta."( Effect of maternal infusion of adrenocorticotrophin1-24 (ACTH1-24) on parturition in guinea-pigs near term.
Schellenberg, JC, 1997
)
0.3
" Further work is required to establish the optimal gestational age and dosage for maternal ACTH administration before clinical recommendations can be given for this therapy."( Effects of maternally administered depot ACTH(1-24) on fetal maturation and the timing of parturition in the mare.
Grainger, L; Houghton, E; Ousey, JC; Palmer, L; Rossdalet, PD, 2000
)
0.31
" Plasma concentrations were near the lower limit of quantitation (50 pg/mL) at the MF DPI 400-microg qd dosage and approximately 250 pg/mL at the 1,200-microg qd dosage."( Mometasone furoate has minimal effects on the hypothalamic-pituitary-adrenal axis when delivered at high doses.
Affrime, MB; Flannery, BE; Herron, JM; Kosoglou, T; Thonoor, CM, 2000
)
0.31
"The MF 800-microg bid dosage (1,600 microg/d), which is twice the highest projected clinical dosage, represents the lower limit for consistently detectable systemic effects of MF."( Mometasone furoate has minimal effects on the hypothalamic-pituitary-adrenal axis when delivered at high doses.
Affrime, MB; Flannery, BE; Herron, JM; Kosoglou, T; Thonoor, CM, 2000
)
0.31
"Once-daily dosing with an effective inhaled corticosteroid (ICS) would likely enhance compliance and, therefore, aid in the management of asthma."( Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler.
Bensch, GW; Karpel, JP; Lutsky, BN; Nolop, KB; Noonan, M; Ramsdell, JW; Webb, DR, 2001
)
0.31
"Several once-daily dosing regimens of mometasone furoate (MF) administered by dry powder inhaler (DPI) were compared with a twice-daily dosing regimen in 286 patients with mild to moderate persistent asthma who were previously being treated with ICS."( Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler.
Bensch, GW; Karpel, JP; Lutsky, BN; Nolop, KB; Noonan, M; Ramsdell, JW; Webb, DR, 2001
)
0.31
" Once-daily dosing offers an effective and convenient treatment that could aid compliance in the treatment of asthma."( Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler.
Bensch, GW; Karpel, JP; Lutsky, BN; Nolop, KB; Noonan, M; Ramsdell, JW; Webb, DR, 2001
)
0.31
"This study sought to determine effects of multiple dosing of prasterone (DHEA, dehydroepiandrosterone) on the pharmacokinetics of prednisolone and endogenous cortisol secretion."( Effects of oral prasterone (dehydroepiandrosterone) on single-dose pharmacokinetics of oral prednisone and cortisol suppression in normal women.
Blum, RA; Jusko, WJ; Meno-Tetang, GM; Schwartz, KE, 2001
)
0.31
" The dosage of synthetic ACTH used in the treatment of WS can be decreased as much as possible to avoid serious adverse effects."( Low-dose ACTH therapy for West syndrome: initial effects and long-term outcome.
Aiba, H; Dejima, S; Fujii, T; Go, T; Hashimoto, K; Hattori, H; Hojo, H; Ikeda, H; Ito, M; Kanazawa, O; Kawamitsu, T; Konishi, Y; Kuroki, S; Matsubara, T; Miki, N; Miyajima, T; Noma, H; Ochi, J; Oguro, K; Okuno, T; Ozaki, N; Sejima, H; Tamamoto, A; Tomiwa, K; Yoshioka, M, 2002
)
0.31
" During 2 infectious episodes, this patient's dosage of hydrocortisone had to be doubled to control symptomatic hypotension, lethargy, diffuse weakness, and anorexia."( Adrenal insufficiency in acute spinal cord injury.
Garcia-Zozaya, IA, 2006
)
0.33
"To determine the dosage and factors influencing efficacy of adrenocorticotropic hormone (ACTH) for West syndrome."( Therapeutic efficacy and adverse effects of adrenocorticotropic hormone therapy in west syndrome: differences in dosage of adrenocorticotropic hormone, onset of age, and cause.
Eto, Y; Hamano, S; Minamitani, M; Tanaka, M; Yamashita, S; Yoshinari, S, 2006
)
0.33
" The lowest dosage group (0."( Therapeutic efficacy and adverse effects of adrenocorticotropic hormone therapy in west syndrome: differences in dosage of adrenocorticotropic hormone, onset of age, and cause.
Eto, Y; Hamano, S; Minamitani, M; Tanaka, M; Yamashita, S; Yoshinari, S, 2006
)
0.33
"Synthetic ACTH therapy at a lower dosage is as effective as natural ACTH therapy at a higher dosage."( Therapeutic efficacy and adverse effects of adrenocorticotropic hormone therapy in west syndrome: differences in dosage of adrenocorticotropic hormone, onset of age, and cause.
Eto, Y; Hamano, S; Minamitani, M; Tanaka, M; Yamashita, S; Yoshinari, S, 2006
)
0.33
"5 dose-response experiments were performed in each of the dogs."( Effect of low doses of cosyntropin on serum cortisol concentrations in clinically normal dogs.
Behrend, EN; Carpenter, DM; Hickey, KC; Martin, LG; Mealey, KL, 2007
)
0.65
" Over the dose range studied no dose-response was observed so the selection of dose should be based on the dose effective to release steroids in the glucocorticoid pathway if this study is to be used in conjunction with such evaluation."( Plasma aldosterone response to the low-dose adrenocorticotrophin (ACTH 1-24) stimulation test.
Bridges, NA; Conway-Phillips, E; Hindmarsh, PC; Honour, JW, 2008
)
0.35
"Cortisol secretion is related to ACTH concentration by a sigmoidal dose-response curve, in which high ACTH concentrations drive maximal cortisol secretion rates (CSR(max))."( Estimation of maximal cortisol secretion rate in healthy humans.
Dorin, RI; Qiao, Z; Qualls, CR; Urban, FK, 2012
)
0.38
" Hydrocortisone is the most common corticosteroid prescribed (93%), with a median dosage of 200 mg/d and administration via intermittent intravenous injection."( US practitioner opinions and prescribing practices regarding corticosteroid therapy for severe sepsis and septic shock.
Anderegg, BA; Bruno, JJ; Dee, BM; Hernandez, M; Pravinkumar, SE, 2012
)
0.38
" Dosage of ACTH, plasma renin active, and basal cortisol and after Synacthen allow to discriminate the subjects with low or high risk of evolution and establish an appropriate monitoring."( [Subclinical adrenal diseases: silent pheochromocytoma and subclinical Addison's disease].
Kerlan, V; Thuillier, P, 2012
)
0.38
" If prednisolone or vigabatrin is used, high dosage is recommended."( Treatment of infantile spasms.
Edwards, SW; Hancock, EC; Osborne, JP, 2013
)
0.39
" There are limited data on evaluating GH and hypothalamic-pituitary-adrenal (HPA) axes using weight-based dosing for the GST."( Revised GH and cortisol cut-points for the glucagon stimulation test in the evaluation of GH and hypothalamic-pituitary-adrenal axes in adults: results from a prospective randomized multicenter study.
Bena, J; Biller, BM; Gordon, MB; Hamrahian, AH; Pulaski-Liebert, KJ; Yuen, KC, 2016
)
0.43
"Studies on 1 μg low-dose test showed that among 1 μg cosyntropin samples pushed through long IV plastic tubing, some adrenocorticotropic hormone dosage was not recovered, and in healthy volunteers it provided subnormal cortisol responses."( Performance of low-dose cosyntropin stimulation test handled via plastic tube.
Abu-Ahmad, A; Chen-Konak, L; Jiries, N; Reut, M; Saiegh, L; Shechner, C; Sheikh-Ahmad, M, 2017
)
1.01
"5 cm plastic tube ensures completeness of the intravenous adrenocorticotropic hormone injection dosage and provides equivalent cortisol responses."( Performance of low-dose cosyntropin stimulation test handled via plastic tube.
Abu-Ahmad, A; Chen-Konak, L; Jiries, N; Reut, M; Saiegh, L; Shechner, C; Sheikh-Ahmad, M, 2017
)
0.76
"We recently published a comparison of two hydrocortisone dosage regimens in patients with septic shock."( Is Inappropriate Response to Cosyntropin Stimulation Test an Indication of Corticosteroid Resistance in Septic Shock?
Barel, R; Bernardin, G; Dellamonica, J; Doyen, D; Goubaux, B; Hyvernat, H; Kaidomar, M; Panaïa-Ferrari, P; Pradier, C, 2018
)
0.77
" There is considerable variation observed both within and between low-dose synacthen dilution methods creating considerable risk of inaccurate dosing and thereby invalid results."( International survey on high- and low-dose synacthen test and assessment of accuracy in preparing low-dose synacthen.
Cross, AS; Elder, CJ; Helen Kemp, E; Krone, NP; Meredith, S; Ross, RJ; Sachdev, P; Walker, L; White, A; Wright, NP, 2018
)
0.48
"5 cm) plastic tube does not alter in-vitro-cosyntropin dosage delivery or healthy-volunteers' morning cortisol responses, we predicted that, when using the same short plastic tube, LDT would show comparable morning and afternoon cortisol stimulation."( Performance of low-dose cosyntropin stimulation test in the afternoon.
Abu-Ahmad, A; Chen-Konak, L; Jiries, N; Reut, M; Saiegh, L; Shechner, C; Sheikh-Ahmad, M, 2019
)
1.08
" Charts were retrospectively reviewed for indication, dosing information, efficacy, and side effects."( Cosyntropin for the Treatment of Refractory Postdural Puncture Headache in Pediatric Patients: A Retrospective Review.
Eisdorfer, S; Gralla, J; Tong, S; Zapapas, MK, 2020
)
2
" Dosing ranged from 5 to 15 mcg/kg (median, 10."( Cosyntropin for the Treatment of Refractory Postdural Puncture Headache in Pediatric Patients: A Retrospective Review.
Eisdorfer, S; Gralla, J; Tong, S; Zapapas, MK, 2020
)
2
" We analyzed the treatment options for infantile spasms, especially regarding the adrenocorticotropic hormone dosage and the formulation (natural versus synthetic) and evaluated which options were more effective in a retrospective cohort from 1960 to 1976."( ACTH Treatment of Infantile Spasms: Low-Moderate- Versus High-Dose, Natural Versus Synthetic ACTH-A Retrospective Cohort Study.
Kokki, H; Lähdetie, J; Riikonen, R, 2020
)
0.56
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,555)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990727 (46.75)18.7374
1990's323 (20.77)18.2507
2000's230 (14.79)29.6817
2010's201 (12.93)24.3611
2020's74 (4.76)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 63.41

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index63.41 (24.57)
Research Supply Index7.50 (2.92)
Research Growth Index4.40 (4.65)
Search Engine Demand Index111.48 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (63.41)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials147 (8.84%)5.53%
Reviews60 (3.61%)6.00%
Case Studies139 (8.36%)4.05%
Observational9 (0.54%)0.25%
Other1,307 (78.64%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (33)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy [NCT03400852]Phase 244 participants (Actual)Interventional2018-07-27Terminated(stopped due to Slow enrollment)
Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease [NCT01371526]Phase 413 participants (Actual)Interventional2010-09-30Completed
Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers [NCT03752190]Phase 40 participants (Actual)Interventional2019-07-31Withdrawn(stopped due to Change in personnel leading to inability to conduct study.)
Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Healthy Children and Adolescent [NCT03709381]Early Phase 110 participants (Actual)Interventional2017-10-01Completed
Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients? [NCT03368066]Phase 3100 participants (Actual)Interventional2018-01-29Completed
Residual Secretion of Adrenal Steroid Hormones in Addison's Disease [NCT03793114]200 participants (Anticipated)Interventional2018-09-26Active, not recruiting
Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study [NCT00694863]Phase 220 participants (Actual)Interventional2008-07-31Completed
Stress and the Nervous System [NCT02339506]23 participants (Actual)Interventional2015-04-30Active, not recruiting
NeSST2: A Multi-stage Clinical Study to Develop a Non-invasive Short Synacthen Test (SST) [NCT03514589]Phase 212 participants (Anticipated)Interventional2012-10-12Recruiting
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE) [NCT02813655]Phase 246 participants (Actual)Interventional2016-10-31Terminated(stopped due to Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05))
Mass Spectrometry Based Cutoffs for Cortisol and 17-hydroxy-progesterone (17-OH-progesterone) After Stimulation Tests for Primary and Secondary Adrenal Insufficiency. [NCT02818660]200 participants (Anticipated)Interventional2016-05-31Recruiting
Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022) [NCT01421797]84 participants (Anticipated)Interventional2006-10-10Active, not recruiting
[NCT00006270]32 participants Observational1998-02-28Active, not recruiting
Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease [NCT00598377]49 participants (Actual)Interventional2006-09-30Completed
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction in Overweight Early Pubertal Girls With Androgen Excess (CBS0004) [NCT01422733]Early Phase 10 participants (Actual)Interventional2018-06-01Withdrawn(stopped due to The study team decided not to pursue this study.)
Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test [NCT00851942]Phase 4165 participants (Actual)Interventional2008-09-30Completed
Re-assessment of Diagnostic Cortisol Values for Adrenal Insufficiency Using a Highly Specific Cortisol Assay [NCT05149638]90 participants (Anticipated)Interventional2022-02-03Recruiting
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS [NCT03905603]Early Phase 1144 participants (Anticipated)Interventional2019-10-08Recruiting
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures [NCT01673087]Phase 1256 participants (Actual)Interventional2012-10-31Completed
The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis [NCT01428336]22 participants (Actual)Interventional2011-09-30Completed
Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients [NCT03083834]50 participants (Anticipated)Interventional2017-03-14Recruiting
Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery [NCT00415701]Phase 4130 participants (Anticipated)Interventional2006-11-30Completed
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome [NCT00989781]41 participants (Actual)Interventional2009-09-30Completed
Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache (PDPH) [NCT02394457]Phase 429 participants (Actual)Interventional2010-08-31Completed
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4) [NCT04546126]Early Phase 124 participants (Anticipated)Interventional2021-11-01Recruiting
Hormonal Mechanisms of Sleep Restriction - Axis Study [NCT03142893]Phase 180 participants (Anticipated)Interventional2017-05-08Active, not recruiting
Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon [NCT03074123]20 participants (Actual)Interventional2017-04-01Completed
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery [NCT01839812]Phase 135 participants (Actual)Interventional2009-03-31Completed
The Adrenal Contribution to Androgen Production in Girls During Puberty [NCT01062568]Phase 350 participants (Actual)Interventional2010-02-28Completed
A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy [NCT03347526]Phase 3394 participants (Anticipated)Interventional2018-04-19Suspended(stopped due to Study on enrollment hold as a precaution per the pharmaceutical company.)
Defining the Mechanisms Underlying Adrenal Dysfunction in Cirrhosis and Its Prognostic Significance [NCT04642391]76 participants (Actual)Observational2021-08-02Active, not recruiting
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women [NCT04037605]Early Phase 15 participants (Actual)Interventional2020-02-09Active, not recruiting
Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Aim 1b: ACTH Stimulation [NCT01764711]13 participants (Actual)Interventional2013-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00989781 (5) [back to overview]Anti-Mullerian Hormone (AMH)
NCT00989781 (5) [back to overview]Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
NCT00989781 (5) [back to overview]17-hydroxyprogesterone Responses to hCG 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]Follicle Count on 3-D Ultrasound 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]Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs
NCT01428336 (3) [back to overview]Pearson Correlation of Free Cortisol Values During CSTs With ITT
NCT01428336 (3) [back to overview]Peak Total Cortisol Values
NCT01764711 (1) [back to overview]Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).
NCT02339506 (2) [back to overview]Hippocampal Memory (Paired Associative Learning Task)
NCT02339506 (2) [back to overview]Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)
NCT02394457 (6) [back to overview]Functioning Score
NCT02394457 (6) [back to overview]Functioning Score
NCT02394457 (6) [back to overview]Functioning Score
NCT02394457 (6) [back to overview]Headache Pain Score
NCT02394457 (6) [back to overview]Headache Pain Score
NCT02394457 (6) [back to overview]Headache Pain Score
NCT03368066 (11) [back to overview]Participant Transplant-Free Survival
NCT03368066 (11) [back to overview]Number of Participants With Spur Cell Anemia
NCT03368066 (11) [back to overview]Number of Participants With Relative Adrenal Insufficiency (RAI)
NCT03368066 (11) [back to overview]Number of Participants With Low Free Cortisol
NCT03368066 (11) [back to overview]Number of Participants With Cholesterol Esterification Deficiency
NCT03368066 (11) [back to overview]Number of Participants Who Received Liver Transplantation at 90 Days
NCT03368066 (11) [back to overview]Number of Participants Who Received Liver Transplantation at 6 Months
NCT03368066 (11) [back to overview]Number of Participants Who Died Within Index Hospitalization
NCT03368066 (11) [back to overview]Number of Participants Who Died at 90 Days
NCT03368066 (11) [back to overview]Number of Participants Who Died at 6 Months
NCT03368066 (11) [back to overview]Number of Participants Who Died at 30 Days
NCT03400852 (8) [back to overview]Quantitative Muscle Testing Scores at Baseline
NCT03400852 (8) [back to overview]Quantitative Muscle Testing Scores at Week 24
NCT03400852 (8) [back to overview]Summary of Adverse Events in the Blinded Treatment Period
NCT03400852 (8) [back to overview]Summary of Adverse Events in the Open Label Period
NCT03400852 (8) [back to overview]Time to Climb 4 Standardized Stairs
NCT03400852 (8) [back to overview]Time to Complete 10 Meter Walk/Run[
NCT03400852 (8) [back to overview]Time to Stand From a Supine Position
NCT03400852 (8) [back to overview]North Star Ambulatory Assessment (NSAA) Score

Anti-Mullerian Hormone (AMH)

(NCT00989781)
Timeframe: Baseline

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).

To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia. (NCT01764711)
Timeframe: 30 minutes after injection of ACTH

Interventionnanograms/dL (Mean)
Low Salt Diet POTS52.5
Low Salt Diet Controls57.9

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Hippocampal Memory (Paired Associative Learning Task)

Hippocampal memory will be evaluated pre and post with a paired associative learning task. Face Name Associative Memory Exam (FNAME) composite score on a scale from 0-36, with 36 being the best possible score. (NCT02339506)
Timeframe: 1 day after ACTH

,
Interventionscore on a scale (Mean)
Baseline1 day after infusion
Cosyntropin27.825.6
Normal Saline (Placebo)29.325.9

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Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)

Cardiovagal baroreflex sensitivity will be measured with the Modified Oxford Technique before, during, and after drug infusions, to evaluate the effects of cosyntropin infusions. (NCT02339506)
Timeframe: Baseline, 4-hours after infusion, 24-hours after infusion

,
Interventionms/mmHg (Mean)
Baseline4-hours after infusion24-hours after infusion
Cosyntropin17.7514.4214.76
Normal Saline (Placebo)16.9017.2718.90

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Functioning Score

Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete activities of daily living (ADLs) (NCT02394457)
Timeframe: 1 day post procedure

Interventionunits on a scale (Mean)
Intravenous Cosyntropin Group A6.53
Epidural Blood Patch Group B2.00

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Functioning Score

Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs (NCT02394457)
Timeframe: 3 day post procedure

Interventionunits on a scale (Mean)
Intravenous Cosyntropin Group A3.20
Epidural Blood Patch Group B2.09

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Functioning Score

Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs (NCT02394457)
Timeframe: 7 day post procedure

Interventionunits on a scale (Mean)
Intravenous Cosyntropin Group A2.14
Epidural Blood Patch Group B1.64

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Headache Pain Score

Numerical 0-10 (0 no pain, 10 worst pain) (NCT02394457)
Timeframe: 1 day post procedure

Interventionunits on a scale (Mean)
Intravenous Cosyntropin Group A6.67
Epidural Blood Patch Group B2.33

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Headache Pain Score

Numerical 0-10 (0 no pain, 10 worst pain) (NCT02394457)
Timeframe: 3 days post procedure

Interventionunits on a scale (Mean)
Intravenous Cosyntropin Group A3.13
Epidural Blood Patch Group B2.36

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Headache Pain Score

Numerical 0-10 (0 no pain, 10 worst pain) (NCT02394457)
Timeframe: 7 days post procedure

Interventionunits on a scale (Mean)
Intravenous Cosyntropin Group A1.93
Epidural Blood Patch Group B1.82

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Participant Transplant-Free Survival

Transplant and Death are considered equivalent outcomes (NCT03368066)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Normal Adrenal Response41
Relative Adrenal Insufficiency16

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Number of Participants With Spur Cell Anemia

A peripheral blood smear will be obtained and assessed for presence of acanthocytes (spur cells). Spur cell anemia is defined as a serum hemoglobin < 10g/dL and the presence of >= 5% spur cells on blood smear. (NCT03368066)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Normal Adrenal Response6
Relative Adrenal Insufficiency8

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Number of Participants With Relative Adrenal Insufficiency (RAI)

A baseline total cortisol level will be obtained and then patients will receive a standard-dose synthetic ACTH (250mcg of Cosyntropin) stimulation test to assess for the presence of adrenal insufficiency. RAI is defined as a change in the total cortisol level in response to the stimulation test of <9mcg/dL when measured 60 minutes after the Cosyntropin is administered. (NCT03368066)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Hospitalized Cirrhosis Patients37

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Number of Participants With Low Free Cortisol

Patients will have their free cortisol levels measured to assess for deficiency. (NCT03368066)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Normal Adrenal Response6
Relative Adrenal Insufficiency1

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Number of Participants With Cholesterol Esterification Deficiency

A percent quantification of serum cholesterol esterification will be measured via blood draw. Low values represent deficiency in esterification, which is a surrogate measure of lecthicin-cholesterol acetyltransferase (LCAT) enzymatic deficiency. (NCT03368066)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Normal Adrenal Response10
Relative Adrenal Insufficiency11

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Number of Participants Who Received Liver Transplantation at 90 Days

Patients who received a liver transplant within 90 days of enrollment (NCT03368066)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Normal Adrenal Response6
Relative Adrenal Insufficiency5

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Number of Participants Who Received Liver Transplantation at 6 Months

Patients who received a liver transplant within 6 months of enrollment (NCT03368066)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Normal Adrenal Response8
Relative Adrenal Insufficiency6

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Number of Participants Who Died Within Index Hospitalization

Patients who died within the same hospitalization as enrollment (NCT03368066)
Timeframe: Within Hospitalization

InterventionParticipants (Count of Participants)
Normal Adrenal Response1
Relative Adrenal Insufficiency1

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Number of Participants Who Died at 90 Days

Patients who died within 90 days of enrollment (NCT03368066)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Normal Adrenal Response5
Relative Adrenal Insufficiency12

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Number of Participants Who Died at 6 Months

Patients who died within 6 months of enrollment (NCT03368066)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Normal Adrenal Response9
Relative Adrenal Insufficiency15

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Number of Participants Who Died at 30 Days

Patients who died within 30 days of enrollment (NCT03368066)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Normal Adrenal Response4
Relative Adrenal Insufficiency4

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Quantitative Muscle Testing Scores at Baseline

Quantitative muscle testing measured strength-knee flexion and extension measured in Newtons, using a dynamometer (NCT03400852)
Timeframe: Baseline

,
InterventionNewtons (Mean)
Knee flexionKnee extension
Period 1: MNK-141126.6128.99
Period 1: Placebo29.8726.64

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Quantitative Muscle Testing Scores at Week 24

Quantitative muscle testing measured strength-knee flexion and extension measured in Newtons, using a dynamometer (NCT03400852)
Timeframe: Week 24

,
InterventionNewtons (Mean)
Knee flexionKnee extension
Period 1: MNK-141133.6426.61
Period 1: Placebo25.2729.87

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Summary of Adverse Events in the Blinded Treatment Period

Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments were reported as adverse events (AEs) (NCT03400852)
Timeframe: within 28 weeks

,
InterventionParticipants (Count of Participants)
ExposedAffected by serious adverse eventsAffected by non-serious adverse eventsDied from any cause
Period 1: MNK-1411290220
Period 1: Placebo151150

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Summary of Adverse Events in the Open Label Period

Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments were reported as adverse events (AEs) (NCT03400852)
Timeframe: within 28 weeks

InterventionParticipants (Count of Participants)
ExposedAffected by serious adverse eventsAffected by non-serious adverse eventsDied from any cause
Period 2: MNK-1411242110

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Time to Climb 4 Standardized Stairs

Time to Climb 4 Standardized Stairs is a motor performance test (NCT03400852)
Timeframe: Baseline, Week 24

,
Interventionseconds (Mean)
at Baselineat Week 24
Period 1: MNK-14118.524.71
Period 1: Placebo8.4715.09

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Time to Complete 10 Meter Walk/Run[

10 Meter Walk/Run is a motor function test to measure the functional capability in patients with DMD. (NCT03400852)
Timeframe: Baseline, Week 24

,
Interventionseconds (Median)
at Baselineat Week 24
Period 1: MNK-14115.95.4
Period 1: Placebo7.88.7

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Time to Stand From a Supine Position

Time to stand from a supine position is a motor function test to measure the functional capability in subjects with DMD. (NCT03400852)
Timeframe: Baseline, Week 24

,
Interventionseconds (Mean)
at Baselineat Week 24
Period 1: MNK-141111.147.65
Period 1: Placebo15.0324.89

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North Star Ambulatory Assessment (NSAA) Score

The NSAA is comprised of 17 items, each of which is graded using the standard scorecard. Each assessment is rated as 0 - unable to achieve independently, 1 - modified method but achieves goal independent of physical assistance from another, or 2 - normal with no obvious modification of activity. The subscale scores are summed for a total score ranging from 0 to 34. The higher the total score, the better the outcome. (NCT03400852)
Timeframe: Baseline, Week 24

,
Interventionscore on a scale (Mean)
at Baselineat Week 24
Period 1: MNK-141117.920.5
Period 1: Placebo17.116.6

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