Clinical trials: Withdrawal
Juvenile Idiopathic Arthritis
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to…
- Trial name
- NCT01230827
- Testing
- CNTO 148 (Golimumab), Methotrexate
- Where
- 35 sites in United States, Austria and 10 more
- Volunteers
- 173 people
- Sponsor
- Janssen Research & Development, LLC
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.
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
Vitiligo
Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who…
- Trial name
- NCT04530344
- Testing
- ruxolitinib, Vehicle
- Where
- 84 sites in United States, Bulgaria and 6 more
- Volunteers
- 458 people
- Sponsor
- Incyte Corporation
Gastroesophageal Reflux Disease (GERD)
Phase 3/Safety & Efficacy of Esomeprazole in Infants
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).
- Trial name
- NCT00468559
- Testing
- Open Label Run In Esomeprazole, Double Blind Esomeprazole
- Where
- 25 sites in United States, France and 2 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Juvenile Rheumatoid Arthritis
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept).
- Trial name
- NCT00095173
- Testing
- Abatacept
- Where
- 36 sites in United States, Austria and 9 more
- Volunteers
- 214 people
- Sponsor
- Bristol-Myers Squibb
Recurrent Pericarditis
Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis
The primary objective of this study was to assess the efficacy of rilonacept treatment in participants with recurrent pericarditis.
- Trial name
- RHAPSODY (NCT03737110)
- Testing
- Rilonacept
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 86 people
- Sponsor
- Kiniksa Pharmaceuticals (UK), Ltd.
Lipodystrophy
Short-term Effects of Leptin in People With Lipodystrophy
Background: Lipodystrophy is a condition where people do not have enough fat in the body. People with lipodystrophy can have problems such as diabetes or an enlarged liver.
- Trial name
- NCT01778556
- Testing
- Metreleptin
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phelan McDermid Syndrome
Growth Hormone Treatment in Children With Phelan McDermid Syndrome
Phelan McDermid syndrome (PMS) is a rare genetic form of autism spectrum disorder (ASD) due to deletions or mutations in the SHANK3 gene.
- Trial name
- NCT04003207
- Testing
- Recombinant human Growth hormone
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Swathi Sethuram
Acute Leukemia, Acute Myeloid Leukemia
A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies
There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD.
- Conditions
- Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Biphenotypic Leukemia
- Trial name
- NCT01036009
- Testing
- Withdrawal of immunosuppression and donor lymphocyte infusion
- Where
- 2 sites in United States
- Volunteers
- 43 people
- Sponsor
- University of California, San Francisco
Cystic Fibrosis
Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be…
- Trial name
- SIMPLIFY-HS (NCT06350461)
- Testing
- Discontinuation of hypertonic saline (HS), Continuation of hypertonic saline (HS)
- Where
- 81 sites in United States
- Volunteers
- 370 people
- Sponsor
- Nicole Hamblett
Primary Fibromyalgia
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
- Trial name
- MyFi (NCT01328002)
- Testing
- Milnacipran
- Where
- 47 sites in United States
- Volunteers
- 116 people
- Sponsor
- Forest Laboratories
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.
Crohn Disease
Crohn Disease Exclusion Diet After Single Medication De-escalation
The primary objective of this study is to determine whether pediatric Crohn Disease (CD) patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet…
- Trial name
- CEASE (NCT02472457)
- Testing
- Crohn Disease Exclusion Diet, Free Diet
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Children's Hospital of Philadelphia
Cystic Fibrosis
Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be…
- Trial name
- SIMPLIFY-DN (NCT06350474)
- Testing
- Discontinuation of dornase alfa (Dnase), Continuation of dornase alfa (Dnase)
- Where
- 81 sites in United States
- Volunteers
- 477 people
- Sponsor
- Nicole Hamblett
Kidney Diseases
Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 (interleukin 2), Tacrolimus…
- Trial name
- NCT00707759
- Testing
- Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone, Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone
- Where
- Chile
- Volunteers
- 28 people
- Sponsor
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Distal Renal Tubular Acidosis
Study Evaluating Subjects With Distal Renal Tubular Acidosis
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in pediatric and…
- Trial name
- NCT03644706
- Testing
- ADV7103
- Where
- 8 sites in United States, Canada
- Volunteers
- 3 people
- Sponsor
- Advicenne Pharma
Liver Transplant, Liver Transplantation
Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ.
- Trial name
- WISP-R (NCT00320606)
- Testing
- Immunosuppression Withdrawal
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hyponatremia
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02012959
- Testing
- Tolvaptan
- Where
- 7 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.