Clinical trials: Withdrawal Syndrome
Constipation Predominant Irritable Bowel Syndrome
A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C
This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by…
- Trial name
- T3MPO-1 (NCT02621892)
- Testing
- Tenapanor
- Where
- 111 sites in United States
- Volunteers
- 606 people
- Sponsor
- Ardelyx
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
Tourette Syndrome
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.
- Trial name
- NCT03530293
- Testing
- Valbenazine
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 81 people
- Sponsor
- Neurocrine Biosciences
Cushing Syndrome
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes…
- Trial name
- GRACE (NCT03697109)
- Testing
- Relacorilant
- Where
- 64 sites in United States, Austria and 9 more
- Volunteers
- 152 people
- Sponsor
- Corcept Therapeutics
Chronic Pain
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
- Trial name
- NCT01100437
- Testing
- EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Pfizer
Neuralgia, Postherpetic, Diabetic Neuropathy
Neuropathic Pain Syndrome Patient Study (MK-0000-072)
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
- Conditions
- Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
- Trial name
- NCT00570310
- Testing
- Comparator: pregabalin
- Volunteers
- 104 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Opioid Withdrawal (Disorder)
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
- Trial name
- TAPER (NCT04070157)
- Testing
- Lofexidine
- Where
- 12 sites in United States
- Volunteers
- 4 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.
Opioid Withdrawal
Open-Label, Safety Study of Lofexidine
The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and…
- Trial name
- NU LEAF (NCT02363998)
- Testing
- Lofexidine
- Where
- 18 sites in United States
- Volunteers
- 286 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Pain
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine…
- Trial name
- NCT01871285
- Testing
- Buprenorphine, Oxycodone, Morphine sulfate
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- BioDelivery Sciences International
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)
Autistic Disorder, Autism
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder…
- Conditions
- Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome
- Trial name
- NCT01592747
- Testing
- Memantine Hydrochloride (HCl)
- Where
- 94 sites in United States, Belgium and 13 more
- Volunteers
- 479 people
- Sponsor
- Forest Laboratories
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
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.
Endogenous Cushing's Syndrome
A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.
This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess…
- Trial name
- NCT03277690
- Testing
- Levoketoconazole
- Where
- 45 sites in United States, Bulgaria and 10 more
- Volunteers
- 84 people
- Sponsor
- Cortendo AB
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Lambert-Eaton Myasthenic Syndrome, Eaton-Lambert Myasthenic Syndrome
Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome
Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.
- Trial name
- DAPPER (NCT01511978)
- Testing
- Continuous 3,4-DAP
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Jacobus Pharmaceutical