Clinical trials: Pediatric ALL
Tourette Syndrome
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with…
- Trial name
- NCT03732534
- Testing
- NBI-98854
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 6 people
- Sponsor
- Neurocrine Biosciences
Type2 Diabetes, Diabetes Mellitus
A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.
- Conditions
- Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, T2D
- Trial name
- SURPASS-PEDS (NCT05260021)
- Testing
- Tirzepatide Dose 1, Tirzepatide Dose 2
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 99 people
- Sponsor
- Eli Lilly and Company
Muscular Dystrophy, Duchenne
A Randomized, Double-blind, Placebo-controlled Study of Delandistrogene Moxeparvovec (SRP-9001) for Duchenne Muscular Dystrophy (DMD)
The purpose of this study is to evaluate the safety and efficacy of exogenous gene transfer in DMD participants by measuring biological and clinical endpoints in three parts: two 48-week randomized, double-blinded…
- Trial name
- NCT03769116
- Testing
- delandistrogene moxeparvovec
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- Sarepta Therapeutics, Inc.
Healthy
A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Antacid in Healthy Adults
A study to learn how different preparations of osivelotor taste and enter the blood with food or liquids, or with an antacid in healthy adults.
- Trial name
- NCT06507904
- Testing
- Osivelotor, Famotidine
- Where
- Belgium
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose.
- Trial name
- NCT04444284
- Testing
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2), Investigational RSV vaccine MV-012-968 (Dosage 3)
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Meissa Vaccines, Inc.
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
- Trial name
- NCT01923311
- Testing
- EVG, Background regimen
- Where
- 11 sites in United States, Italy and 4 more
- Volunteers
- 31 people
- Sponsor
- Gilead Sciences
Influenza
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
- Trial name
- NCT00972816
- Testing
- MF59-eH1N1
- Where
- 35 sites in United States, Mexico
- Volunteers
- 1,357 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Heart Failure
A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
The purpose of this open-label study was to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed…
- Trial name
- NCT06149104
- Testing
- sacubitril/valsartan
- Where
- 6 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma.
- Trial name
- NCT01899144
- Testing
- Albuterol Spiromax, ProAir HFA
- Where
- 22 sites in United States
- Volunteers
- 61 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Healthy Participants
A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants
The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants.
- Trial name
- INS1007 (NCT06344728)
- Testing
- Brensocatib Oral Solution, Brensocatib Oral Tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Insmed Incorporated
Hydrocephalus, Nervous System Diseases
Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts. The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies…
- Conditions
- Hydrocephalus, Nervous System Diseases, Infant, Newborn Diseases
- Trial name
- NCT01108965
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Transonic Systems Inc.
Type 2 Diabetes Mellitus
A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)
The purpose of this study is to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to the addition of placebo on glycated hemoglobin (A1C), and the safety and tolerability of the…
- Trial name
- NCT01760447
- Testing
- Sitagliptin plus metformin, Metformin, Sitagliptin plus metformin XR
- Volunteers
- 223 people
- Sponsor
- Merck Sharp & Dohme LLC
Skin; Deformity
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only).
- Trial name
- NCT03624192
- Testing
- RECELL® Autologous Cell Harvesting Device, Telfa™ Clear and Xeroform™ dressings
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Avita Medical
ADHD, ADD
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
- Trial name
- NCT00301236
- Testing
- Dexmethylphenidate HCl extended-release capsules
- Where
- 25 sites in United States
- Volunteers
- 252 people
- Sponsor
- Novartis
Acute Bacterial Skin and Skin Structure Infection
Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections
This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric…
- Trial name
- NCT05599295
- Testing
- Orbactiv, Kimyrsa
- Where
- 23 sites in United States, Bulgaria and 6 more
- Volunteers
- 118 people
- Sponsor
- Melinta Therapeutics, LLC
Attention-deficit Hyperactivity Disorder
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.
- Trial name
- NCT04786730
- Testing
- Centanafadine
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Rabies Post-exposure Prophylaxis
SYN023 With Rabies Vaccine in Healthy Pediatric Subjects
This study is a randomized, double-blind, active-controlled design. The goal is to evaluate the safety, pharmacokinetics and pharmacodynamic of SYN023 in combination with rabies vaccine in healthy participants under 18 years of…
- Trial name
- NCT07342257
- Testing
- SYN023, Rabies Vaccine, HRIG
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Synermore Biologics (Suzhou) Co., Ltd.
Irritable Bowel Syndrome
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of…
- Trial name
- NCT03339128
- Testing
- Eluxadoline
- Where
- 46 sites in United States, Bulgaria and 7 more
- Volunteers
- 272 people
- Sponsor
- AbbVie
Neuroblastoma, CNS Metastases
131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases will be given up to 2 rounds of intracerebroventricular treatment with a radiolabelled monoclonal antibody, 131I-omburtamab to…
- Conditions
- Neuroblastoma, CNS Metastases, Leptomeningeal Metastases
- Trial name
- NCT03275402
- Testing
- 131I-omburtamab
- Where
- 8 sites in United States, Denmark and 2 more
- Volunteers
- 52 people
- Sponsor
- Y-mAbs Therapeutics