Clinical trials: Withdrawal
Rheumatoid Arthritis
Phase IIIB Subcutaneous Missed Dose Study
The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.
- Trial name
- NCT00533897
- Testing
- Abatacept
- Where
- 27 sites in United States, Argentina and 3 more
- Volunteers
- 270 people
- Sponsor
- Bristol-Myers Squibb
Major Depressive Disorder
Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants
GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major depressive disorder (depression) who have responded inadequately to another antidepressant drug during the current episode.
- Trial name
- NCT01684163
- Testing
- GLYX-13 5 mg/kg, GLYX-13 10 mg/kg
- Where
- 26 sites in United States
- Volunteers
- 369 people
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
Leptin Receptor Deficiency Obesity
Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with LEPR deficiency obesity due to rare bi-allelic or loss-of function mutations at the…
- Trial name
- NCT03287960
- Testing
- Setmelanotide
- Where
- 6 sites in Canada, France and 4 more
- Volunteers
- 15 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Chronic Low Back Pain
Phase 2 Chronic Low Back Pain Study
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
- Trial name
- NCT01364922
- Testing
- hydrocodone/acetaminophen extended release
- Where
- 17 sites in United States
- Volunteers
- 168 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Maintenance Renal Transplantation
Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,
The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft recipients.
- Trial name
- NCT00239057
- Testing
- Enteric-Coated Mycophenolate Sodium
- Volunteers
- 23 people
- Sponsor
- Novartis
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
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.
Major Depressive Disorder
To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets
This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the…
- Trial name
- NCT06426485
- Testing
- Toludesvenlafaxine Hydrochloride Sustained-release Tablets
- Volunteers
- 736 people
- Sponsor
- Luye Pharma Group Ltd.
Hypertension
A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.
To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.
- Trial name
- NCT00219063
- Testing
- aliskiren
- Where
- United States
- Volunteers
- 844 people
- Sponsor
- Novartis
Hemodialysis
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in…
- Trial name
- NCT05533008
- Testing
- CR845 0.5 mcg/kg
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Cara Therapeutics, Inc.
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
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)
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
Uterine Leiomyoma, Uterine Fibroids
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients…
- Trial name
- NCT03751124
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 104 sites in United States, Brazil and 6 more
- Volunteers
- 229 people
- Sponsor
- Myovant Sciences GmbH
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.
Pain, Peripheral Neuropathy
A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.
- Trial name
- NCT00713323
- Testing
- Sativex®
- Where
- United Kingdom
- Volunteers
- 380 people
- Sponsor
- Jazz Pharmaceuticals
Oral Contraceptive
Comparative Trial in Hormone Withdrawal Associated Symptoms
This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a…
- Trial name
- NCT01076582
- Testing
- EE20/DRSP (YAZ, BAY86-5300), Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)
- Where
- 44 sites in Argentina, Chile and 12 more
- Volunteers
- 592 people
- Sponsor
- Bayer
Opioid Dependence, Buprenorphine Withdrawal Syndrome
Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients
The primary objective of this study is to assess lofexidine related effects on QTc (an interval of the heart rhythm) in subjects receiving buprenorphine maintenance.
- Trial name
- NCT01820442
- Testing
- Lofexidine HCl, Lofexidine-matching sugar pill
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Essential Tremor
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
- Trial name
- NCT02978781
- Testing
- SAGE-217
- Where
- 26 sites in United States
- Volunteers
- 34 people
- Sponsor
- Biogen
Chronic Cluster Headache
A First-in-human Study to Assess the Initial Safety, Tolerability, and Effectiveness of the ONSS Bilateral Occipital Nerve Field Stimulation System for the Prophylactic Treatment of Chronic Cluster Headache in Difficult-to-treat Subjects.
The purpose of this clinical trial is to evaluate the safety and effectiveness of the Occipital Nerve Stimulation System (ONSS) in treating chronic cluster headache in adults.
- Trial name
- ONFIELD (NCT07677137)
- Testing
- Occipital Nerve Stimulation System
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Man and Science, SA