Clinical trials: Withdrawal Syndrome
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Opiate Withdrawal Syndrome
A Study of Oral Ibogaine in Opioid Withdrawal
Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a…
- Trial name
- NCT05029401
- Testing
- DMX-1002
- Where
- 2 sites in United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- atai Therapeutics, Inc.
Prader-Willi Syndrome
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
This is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are…
- Trial name
- NCT02034071
- Testing
- DCCR
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Essentialis, Inc.
Opioid Dependence, Methadone Withdrawal Syndrome
Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients
The primary objective of this study is to assess QTc (an interval of the heart rhythm) interaction effects between lofexidine and methadone.
- Trial name
- NCT01558934
- Testing
- Lofexidine HCl
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations
Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations
This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.
- Trial name
- MASter-1 (NCT04641442)
- Testing
- MAS825
- Where
- 12 sites in United States, Czechia and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Irritable Bowel Syndrome Characterized by Constipation
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).
- Trial name
- NCT00948818
- Testing
- Linaclotide 290 micrograms
- Where
- 118 sites in United States, Canada
- Volunteers
- 803 people
- Sponsor
- Forest Laboratories
Behcet's Disease Uveitis
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).
- Trial name
- EYEGUARD™-US (NCT02258867)
- Testing
- Gevokizumab
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- XOMA (US) LLC
Post-Concussion Syndrome
ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion
This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic…
- Trial name
- NCT04744051
- Testing
- 50 Adipose Derived Stem Cell Infusion, 150 Adipose Derived Stem Cell Infusion, 300 Adipose Derived Stem Cell Infusion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- American CryoStem Corporation
Substance Withdrawal Syndrome, Opiate Addiction
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
- Conditions
- Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
- Trial name
- NCT02801357
- Testing
- lofexidine administration in subjects seeking buprenorphine dose reduction
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Tourette Syndrome
Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents
This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance…
- Trial name
- ARTISTS (NCT03567291)
- Testing
- TEV-50717
- Where
- 76 sites in United States, Argentina and 13 more
- Volunteers
- 228 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Irritable Bowel Syndrome With Diarrhea
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea.
- Trial name
- IRIS-3 (NCT02107196)
- Testing
- Ibodutant 10 mg
- Where
- 127 sites in United States, Bulgaria and 9 more
- Volunteers
- 535 people
- Sponsor
- Menarini Group
Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria
Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1).
- Conditions
- Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria, Muckle-Wells Syndrome (MWS), Genetic Diseases, Inborn
- Trial name
- NCT00288704
- Testing
- rilonacept 160 mg
- Where
- 24 sites in United States
- Volunteers
- 104 people
- Sponsor
- Regeneron Pharmaceuticals
Irritable Bowel Syndrome Characterized by Constipation
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
- Trial name
- NCT03573908
- Testing
- Linaclotide
- Where
- 79 sites in United States
- Volunteers
- 614 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Irritable Bowel Syndrome
DARWIN Study: A Randomization/Withdrawal Efficacy Study of Dexloxiglumide in Constipation-Predominant Irritable Bowel Syndrome (C-IBS)
Irritable Bowel Syndrome (IBS) is the most commonly identified functional gastrointestinal disorder, affecting 10-20% of the population in the Western world, seen predominantly in females and with a negative impact on quality of…
- Trial name
- NCT00220090
- Testing
- dexloxiglumide
- Where
- United Kingdom
- Sponsor
- Rottapharm
Tourette Disorder
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD).
- Trial name
- D1AMOND (NCT05615220)
- Testing
- Ecopipam Hydrochloride
- Where
- 95 sites in United States, Bulgaria and 10 more
- Volunteers
- 216 people
- Sponsor
- Emalex Biosciences Inc.
Withdrawal Symptoms
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects…
- Trial name
- NCT02391571
- Testing
- Oxycodone/Naltrexone Capsules, Oxycodone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Elite Laboratories, Inc
Psoriasis
A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at…
- Trial name
- NCT01186744
- Testing
- CP-690,550
- Where
- 87 sites in United States, Argentina and 10 more
- Volunteers
- 666 people
- Sponsor
- Pfizer
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Obstructive Sleep Apnea
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348619)
- Testing
- JZP-110
- Where
- 30 sites in United States, Finland and 3 more
- Volunteers
- 174 people
- Sponsor
- Jazz Pharmaceuticals