Clinical trials: Disorder, Pediatric
Tourette Syndrome
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
- Trial name
- NCT03444038
- Testing
- Valbenazine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 85 people
- Sponsor
- Neurocrine Biosciences
Congenital Heart Disease
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
The investigators hypothesize that intermittent bolus doses of morphine and midazolam can provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus infusions while using smaller total doses of both…
- Trial name
- NCT02112448
- Testing
- continuous infusion, as needed dosing, Acetaminophen
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Wake Forest University Health Sciences
Familial Hypercholesterolemia
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind…
- Trial name
- NCT00355615
- Testing
- Rosuvastatin
- Where
- 20 sites in United States, Canada and 3 more
- Volunteers
- 173 people
- Sponsor
- AstraZeneca
Fragile x Syndrome
Ganaxolone Treatment in Children With Fragile X Syndrome
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (FXS).
- Trial name
- NCT01725152
- Testing
- Ganaxolone
- Where
- 2 sites in United States, Belgium
- Volunteers
- 59 people
- Sponsor
- Marinus Pharmaceuticals
Otitis Media, Infections, Respiratory Tract
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses.
- Conditions
- Otitis Media, Infections, Respiratory Tract, Respiratory Tract Infections
- Trial name
- NCT04600752
- Testing
- Augmentin (ES)-600
- Where
- 13 sites in India
- Volunteers
- 310 people
- Sponsor
- GlaxoSmithKline
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
Acute Lymphoblastic Leukemia
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL
This is a phase 2 study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia.
- Trial name
- NCT03792633
- Testing
- huCART19
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- University of Pennsylvania
B-Cell Pediatric ALL
Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma.
- Trial name
- NCT02227108
- Testing
- Moxetumomab Pasudotox
- Where
- 21 sites in United States, Australia and 6 more
- Volunteers
- 37 people
- Sponsor
- MedImmune LLC
Recurrent Tonsillitis, Obstructive Sleep Apnea
Post-operative Pain Control After Pediatric Adenotonsillectomy
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in…
- Conditions
- Recurrent Tonsillitis, Obstructive Sleep Apnea, Sleep Disordered Breathing, Adverse Reaction to Drug
- Trial name
- NCT02296840
- Testing
- Ibuprofen, Hydrocodone-Acetaminophen
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Emory University
Hemophilia B
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B
The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of…
- Trial name
- NCT01271868
- Testing
- IB1001
- Where
- 10 sites in United States, India and 1 more
- Volunteers
- 9 people
- Sponsor
- Medexus Pharma, Inc.
Oesophagitis, Eosinophilic
Intravenous Mepolizumab In Children With Eosinophilic Esophagitis
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
- Trial name
- NCT00358449
- Testing
- mepolizumab
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 84 people
- Sponsor
- GlaxoSmithKline
PFIC1, PFIC2
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- PEDFIC 1 (NCT03566238)
- Testing
- A4250 (odevixibat)
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 62 people
- Sponsor
- Albireo
Obesity
Exenatide in Extreme Pediatric Obesity
Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM).
- Trial name
- NCT01237197
- Testing
- Exenatide
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- University of Minnesota
Pediatric Obesity, Meal Timing
Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity
In adolescents, conventional obesity treatment comprehensively addresses nutritional, activity, and behavioral topics. Due to limited resources in historically marginalized communities, implementation of nutrition-based…
- Trial name
- NCT05391438
- Testing
- Meal-timing
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Hospital Los Angeles
Functional Gastrointestinal Disorders
Systematic Pediatric Assessment of Rome Criteria (SPARC)
While gastroenterologists care for many of the pediatric patients with Functional gastrointestinal disorders (FGIDs), the majority of the burden continues to be borne by general pediatricians, especially with respect to initial…
- Trial name
- SPARC (NCT04773158)
- Testing
- Clinical Decision Support
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Indiana University
Dilated Cardiomyopathy
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy
A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.
- Trial name
- TICAP-DCM (NCT03129568)
- Testing
- CDC infusion
- Where
- Japan
- Volunteers
- 5 people
- Sponsor
- Okayama University
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Amplified Musculoskeletal Pain Syndrome, Reflex Sympathetic Dystrophy
Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
A pilot randomized controlled trial to assess feasibility, acceptability and generate outcome domains for a future RCT testing the efficacy of immersive virtual reality on pain intensity in pediatric amplified musculoskeletal…
- Conditions
- Amplified Musculoskeletal Pain Syndrome, Reflex Sympathetic Dystrophy, Complex Regional Pain Syndromes
- Trial name
- NCT03762213
- Testing
- Oculus GO VR HMD, application Happy Place (© Mimerse), iPad, application Happy Place (© Mimerse)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Tufts Medical Center
Obesity, Childhood, Behavior, Health
Summer Youth Employment Programs for Health Promotion
The purpose of this proof-of-concept study is to assess the initial signal of effectiveness of summer youth employment programs (SYEP) on understudied obesity-related outcomes in adolescents.
- Conditions
- Obesity, Childhood, Behavior, Health, Healthy Lifestyle
- Trial name
- NCT07227220
- Testing
- Summer Youth Employment Program
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Houston
Partial Onset Seizures
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures.
- Trial name
- NCT02072824
- Testing
- Pregabalin Dose Level 1, Pregabalin Dose Level 2
- Where
- 72 sites in United States, Belarus and 21 more
- Volunteers
- 175 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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