Clinical trials: Pediatric Safety and Effectiveness
Congenital Myasthenic Syndrome, CMS
A Study to Assess Efficacy and Safety of Adimanebart in Adult and Pediatric Participants With DOK7-,MUSK-, AGRN-, or LRP4- Congenital Myasthenic Syndromes (CMS)
The purpose of this study is to assess efficacy and safety of adimanebart in participants at least 12 years of age with DOK7-, MUSK-, AGRN-, or LRP4- Congenital Myasthenic Syndromes (CMS).
- Trial name
- CoMetS (NCT07746089)
- Testing
- Adimanebart IV
- Volunteers
- 105 people
- Sponsor
- argenx
Renal Insufficiency, Chronic
Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome
This is a phase III, multi-centre, randomised, placebo-controlled, patient and investigator-blind study in paediatric patients with early stages of Alport syndrome to assess the safety and efficacy of the ACEi ramipril in slowing…
- Trial name
- NCT01485978
- Testing
- Ramipril
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Pediatric ALL
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
- Trial name
- NCT04851717
- Testing
- Remimazolam
- Where
- 8 sites in United States, Denmark
- Volunteers
- 100 people
- Sponsor
- Acacia Pharma Ltd
Phelan-McDermid Syndrome
An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
This Phase 3, open-label extension, multicenter study will evaluate long-term safety, tolerability and efficacy of NNZ-2591 in pediatric participants with Phelan- McDermid Syndrome.
- Trial name
- NCT07593391
- Testing
- NNZ-2591
- Where
- 11 sites in United States
- Volunteers
- 180 people
- Sponsor
- Neuren Pharmaceuticals Limited
Asthma
Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period.
- Trial name
- NCT02113436
- Testing
- FP/ SLM HFA MDI 50/25 mcg, FP HFA MDI 50 mcg
- Where
- 69 sites in Japan
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Child Obesity, Bowel Preparation
Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.
- Trial name
- NCT04525560
- Testing
- PEG-ELS-S, PEG-ELS-L
- Where
- China
- Volunteers
- 315 people
- Sponsor
- Children's Hospital of Fudan University
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study.
- Trial name
- ENVISION (NCT05881408)
- Testing
- delandistrogene moxeparvovec
- Where
- 46 sites in United States, Australia and 12 more
- Volunteers
- 148 people
- Sponsor
- Sarepta Therapeutics, Inc.
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
PIK3CA-related Overgrowth Spectrum (PROS)
Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
This Phase II, multicenter, open-label study, preceded by a retrospective non-interventional period, is assessing the long-term safety and efficacy of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth…
- Trial name
- EPIK-P3 (NCT04980833)
- Testing
- Alpelisib
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Soil-Transmitted Helminthiasis (STH)
Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Effectiveness and Safety of ZP5-9676 for the Treatment of Soil Transmitted Helminthiasis (STH)
This is a Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectiveness, safety, and tolerability of ZP5-9676 compared to placebo for the treatment of STH infections.
- Trial name
- NCT06128447
- Testing
- ZP5-9676 600 mg dose
- Where
- Brazil
- Volunteers
- 300 people
- Sponsor
- Zero Point Five Therapeutics
Proliferative Vitreoretinopathy
Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients
Rhegmatogenous retinal detachment (RRD) is a sight-threatening condition. Children with RRD usually present late with clinical features of longstanding RRD, specifically a serious condition named: proliferative vitreoretinopathy…
- Trial name
- SIGHT (NCT04830878)
- Testing
- Methotrexate
- Where
- United States
- Sponsor
- Stanford University
Nasal Congestion and Inflammations, Rhinitis
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion…
- Trial name
- NCT01393548
- Testing
- brompheniramine + phenylephrine, Brompheniramine + pseudoephedrine
- Where
- Brazil
- Volunteers
- 879 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
Diabetes Mellitus, Hypertension
Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and…
- Conditions
- Diabetes Mellitus, Hypertension, Metabolic Disease, Obesity
- Trial name
- NCT00001723
- Testing
- Orlistat
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Jack Yanovski
Neuropathic Pains, Vasoocclusive Sickle Cell Crises Pains
Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic zoster adult pains. This treatment is recommended in first intention in adult neuropathic pains with allodynia.
- Trial name
- NCT01314300
- Testing
- Lidocaine
- Where
- 2 sites in France
- Volunteers
- 39 people
- Sponsor
- Centre Leon Berard
Recurrent Diffuse Pontine Gliomas
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG)…
- Trial name
- NCT00600054
- Testing
- nimotuzumab (anti EGFR humanized monoclonal antibody)
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 44 people
- Sponsor
- YM BioSciences
Epilepsy
Pediatric Epilepsy Trial in Subjects 1-24 Months
This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures.
- Trial name
- NCT00043875
- Testing
- lamotrigine
- Where
- 65 sites in United States, Australia and 12 more
- Volunteers
- 177 people
- Sponsor
- GlaxoSmithKline
Attention Deficit Hyperactivity Disorder, Attention-Deficit / Hyperactivity Disorder
A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter bridging clinical trial designed to evaluate the efficacy and safety of viloxazine extended-release capsules (AK-D101) compared with placebo in Korean…
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention-Deficit / Hyperactivity Disorder, ADHD
- Trial name
- AK-D101_BS (NCT07678827)
- Testing
- AK-D101
- Where
- South Korea
- Volunteers
- 156 people
- Sponsor
- Alvogen Korea
Glycogen Storage Disease Type II Infantile Onset
A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18
This is a Phase 3, open-label, multicenter study to evaluate the safety, efficacy, PK, PD, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ERT-experienced and ERT-naïve pediatric subjects with IOPD.
- Trial name
- ROSSELLA (NCT04808505)
- Testing
- Cipaglucosidase alfa, Miglustat
- Where
- 14 sites in United States, Germany and 4 more
- Volunteers
- 36 people
- Sponsor
- Amicus Therapeutics
Invasive Aspergillosis
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to <18 years of age with invasive aspergillosis (IA).
- Trial name
- NCT04218851
- Testing
- Posaconazole IV, Posaconazole PFS, Posaconazole tablet
- Where
- 29 sites in United States, Belgium and 8 more
- Volunteers
- 31 people
- Sponsor
- Merck Sharp & Dohme LLC
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