Clinical trials: Disorder, Pediatric
Duchenne Muscular Dystrophy, Duchenne
Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients
Phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and < 10 years. The trial has two parts. In Part 1, the trial will study two doses of SAT-3247 in a randomized, double-blind, placebo-controlled weekday regimen for…
- Conditions
- Duchenne Muscular Dystrophy, Duchenne, DMD, Neuromuscular Diseases
- Trial name
- BASECAMP (NCT07287189)
- Testing
- SAT-3247
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 51 people
- Sponsor
- Satellos Bioscience, Inc.
Hearing Loss
Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
The study is a non-interventional, observational, study on users of Ponto sound processors who use their sound processors on a softband solution.
- Trial name
- NCT06638840
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Oticon Medical
Rhinitis, Allergic, Perennial
Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis
To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and intermittent allergic rhinitis.
- Trial name
- NCT00741897
- Testing
- Fexofenadine
- Where
- Philippines
- Volunteers
- 264 people
- Sponsor
- Sanofi
Tumors, Hyperuricemia
Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy
This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor…
- Conditions
- Tumors, Hyperuricemia, Tumor Lysis Syndrome
- Trial name
- NCT00230217
- Testing
- Rasburicase (SR29142)
- Where
- 7 sites in United States
- Volunteers
- 94 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
- Trial name
- BLOSSOM (NCT05835310)
- Testing
- Anifrolumab
- Where
- 103 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Attention Deficit Hyperactivity Disorder (ADHD)
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study.
- Trial name
- NCT02691182
- Testing
- SPN-810
- Where
- United States
- Volunteers
- 491 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Epilepsy
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
- Trial name
- NCT05076838
- Testing
- Diazepam Nasal Spray [Valtoco]
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Neurelis, Inc.
Type 2 Diabetes Mellitus
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and…
- Trial name
- NCT01525225
- Testing
- Metformin immediate release (IR), Saxagliptin, Metformin IR
- Where
- 7 sites in United States
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
Progressive Familial Intrahepatic Cholestasis (PFIC)
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX).
- Trial name
- INDIGO (NCT02057718)
- Testing
- LUM001 (Maralixibat)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Glycogen Storage Disease Type IA
Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa
The primary objective of this study is to assess the percentage of time patients were in normal glucose control.
- Trial name
- NCT04708015
- Testing
- No Intervention
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 15 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06690398
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 35 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Atopic Dermatitis
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
- Trial name
- NCT03961529
- Testing
- 0.3% OPA-15406 ointment, 1% OPA-15406 ointment
- Where
- Japan
- Volunteers
- 366 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Iron Deficiency Anemia
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to <18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA.
- Trial name
- NCT03893045
- Testing
- ferumoxytol, Iron sucrose
- Where
- 15 sites in United States, Lithuania and 1 more
- Volunteers
- 75 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Central Precocious Puberty
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with…
- Trial name
- NCT06129539
- Testing
- Debio 4326
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 56 people
- Sponsor
- Debiopharm International SA
Attention Deficit Hyperactivity Disorder
Dasotraline Pediatric Extension Study
This is an open label 26 week extension study for subjects who completed SEP360-202.
- Trial name
- NCT02457819
- Testing
- Dasotraline
- Where
- 36 sites in United States
- Volunteers
- 237 people
- Sponsor
- Sumitomo Pharma America, Inc.
Hypertension
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
- Trial name
- NCT00756938
- Testing
- losartan potassium
- Volunteers
- 101 people
- Sponsor
- Organon and Co
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
- Trial name
- NCT02131623
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Niemann-Pick Diseases, Acid Sphingomyelinase Deficiency
A Real-world Long-term Safety and Immunogenicity Study of Olipudase Alfa Therapy in Pediatric Patients Less Than 2 Years of Age With Acid Sphingomyelinase Deficiency (ASMD)
US, multicenter, cohort, open label observational study with primary data collection. Ancillary protocol-specified procedures to address the study objectives (eg, assessment of ADA) may be considered outside the standard of care…
- Trial name
- NCT06192576
- Testing
- Olipudase alfa
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sanofi
Malignant Melanoma
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric…
- Trial name
- NCT01519323
- Testing
- vemurafenib
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche
Exocrine Pancreatic Insuficiency
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant.
- Trial name
- NCT07335523
- Testing
- Fecal Fat
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
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