Clinical trials: Withdrawal
Opioid-use Disorder, Opioid Withdrawal
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate…
- Trial name
- NCT04075214
- Testing
- transcutaneous auricular neurostimulation (tAN)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Spark Biomedical, Inc.
Narcolepsy, Idiopathic Hypersomnia
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
- Trial name
- XYRISE (NCT07625280)
- Testing
- Xywav
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
Management of Chronic Pain
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
- Trial name
- NCT01709721
- Testing
- Hydromorphone Hydrochloride, Programmable Implantable pump
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Piramal Critical Care, Ltd.
Vitiligo
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo.
- Trial name
- Tranquillo LTE (NCT06163326)
- Testing
- Ritlecitinib, Ritlecitinib 100 mg
- Where
- 73 sites in United States, Australia and 11 more
- Volunteers
- 394 people
- Sponsor
- Pfizer
Gastroesophageal Reflux
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of…
- Trial name
- NCT00992589
- Testing
- Rabeprazole sodium 5 mg, Rabeprazole sodium 10 mg
- Where
- 81 sites in United States, Australia and 8 more
- Volunteers
- 344 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Diabetic Neuropathy
A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with moderate to severe pain from diabetic…
- Trial name
- NCT00455520
- Testing
- CG5503
- Volunteers
- 395 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Antibody-mediated Rejection
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
- Trial name
- NCT03221842
- Testing
- C1-esterase inhibitor
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
Hidradenitis Suppurativa
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens…
- Trial name
- NCT04179175
- Testing
- secukinumab
- Where
- 191 sites in United States, Argentina and 36 more
- Volunteers
- 702 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
Breast Cancer
Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients
- Trial name
- SOSTA (NCT00727883)
- Volunteers
- 190 people
- Sponsor
- AstraZeneca
Spasticity, Multiple Sclerosis
Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis
The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from…
- Trial name
- NCT00702468
- Testing
- Sativex
- Where
- United Kingdom
- Volunteers
- 36 people
- Sponsor
- Jazz Pharmaceuticals
Renal Transplantation
A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
- Trial name
- NCT00650468
- Testing
- tacrolimus, CellCept, steroids (methylprednisone or prednisone)
- Where
- 29 sites in United States
- Volunteers
- 397 people
- Sponsor
- Astellas Pharma Inc
Fragile X Syndrome
Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days).
- Trial name
- Harbor-C (NCT01325220)
- Testing
- arbaclofen
- Where
- 28 sites in United States
- Volunteers
- 172 people
- Sponsor
- Seaside Therapeutics, Inc.
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
- Trial name
- NCT03714373
- Testing
- DCCR
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 115 people
- Sponsor
- Soleno Therapeutics, Inc.
Narcolepsy
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.
- Trial name
- NCT00366080
- Testing
- GSK189254
- Where
- 14 sites in Austria, Finland and 4 more
- Volunteers
- 69 people
- Sponsor
- GlaxoSmithKline
Bipolar I Disorder, Mania
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e.
- Conditions
- Bipolar I Disorder, Mania, Depression
- Trial name
- NCT03573297
- Testing
- Cariprazine
- Where
- 108 sites in United States, Bulgaria and 9 more
- Volunteers
- 901 people
- Sponsor
- AbbVie
Psoriasis
IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis
- Trial name
- NCT06049810
- Testing
- IBI112
- Where
- China
- Volunteers
- 566 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Bipolar Disorder, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioXcel Therapeutics Inc
Uremic Pruritus
A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with…
- Trial name
- AC120-8231 (NCT00793156)
- Testing
- Nalfurafine HCl 2.5 µg, Nalfurafine HCl 5.0 µg
- Volunteers
- 350 people
- Sponsor
- Acologix, Inc.
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