Clinical trials: Pediatric Safety and Effectiveness
Epileptic Encephalopathy, Continuous Spike and Wave During Sleep
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous…
- Trial name
- NCT04625101
- Testing
- NBI-827104
- Where
- 15 sites in United States, Canada and 4 more
- Volunteers
- 24 people
- Sponsor
- Neurocrine Biosciences
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma
Epilepsy
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently have uncontrolled partial onset seizures.
- Trial name
- NCT01921205
- Testing
- Lacosamide
- Where
- 118 sites in United States, Argentina and 26 more
- Volunteers
- 404 people
- Sponsor
- UCB Pharma
Neurogenic Detrusor Overactivity, Pediatric
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.
- Trial name
- NCT01981954
- Testing
- Solifenacin succinate
- Where
- 8 sites in United States, Belgium and 4 more
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Europe B.V.
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Epilepsies, Partial
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: The frequency of treatment related adverse events.
- Trial name
- NCT01441401
- Testing
- gabapentin
- Volunteers
- 82 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Autistic Spectrum Disorders
TSO in Pediatric Autistic Spectrum Disorders
The primary objective of this study is to evaluate and compare the safety and efficacy of Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism.
- Trial name
- TSO (NCT01734941)
- Testing
- TSO
- Where
- Israel
- Volunteers
- 9 people
- Sponsor
- Hadassah Medical Organization
Alopecia Areata, Pediatric Disorder
Efficacy and Safety of LH-8 in Paediatric Alopecia Areata
Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution versus placebo in children and adolescents with moderate to severe scalp alopecia areata.
- Trial name
- AA (NCT03240627)
- Testing
- LH-8
- Where
- 3 sites in Bulgaria, France and 1 more
- Volunteers
- 107 people
- Sponsor
- Legacy Healthcare SA
Systemic Aspergillosis, Systemic Candidiasis
Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation
Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic…
- Trial name
- NCT01040156
- Where
- Germany
- Sponsor
- University Children's Hospital Tuebingen
Post-Operative Pain, Acute Pain
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.
- Trial name
- NCT02687451
- Testing
- Oxymorphone HCl
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Acute Stress Disorder, Anxiety
Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room
The hypothesis is that intranasal dexmedetomidine will provide significantly more effective analgesia and anxiolysis for subjects undergoing a simple laceration repair when compared to either intranasal fentanyl or intranasal…
- Conditions
- Acute Stress Disorder, Anxiety, Pain
- Trial name
- NCT05057689
- Testing
- Intranasal Dexmedetomidine (4 mcg/kg), Intranasal Fentanyl (2 mcg/kg), Intranasal Midazolam (5 mg/kg)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Functional Constipation
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.
- Trial name
- NCT04110145
- Testing
- Linaclotide
- Where
- 18 sites in United States
- Volunteers
- 35 people
- Sponsor
- Allergan
Hereditary Angioedema (HAE)
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.
- Trial name
- NCT05819775
- Testing
- CSL312
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 22 people
- Sponsor
- CSL Behring
Sickle Cell Disease
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
The main purpose of the study is to evaluate the efficacy and safety of the study drug known as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with sickle cell disease.
- Trial name
- NCT01794000
- Testing
- Prasugrel
- Where
- 50 sites in United States, Belgium and 12 more
- Volunteers
- 341 people
- Sponsor
- Eli Lilly and Company
Common Cold, Influenza
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old…
- Trial name
- ACCORD (NCT02644018)
- Testing
- Imidazolyl ethanamide pentandioic acid
- Where
- 13 sites in Russia
- Volunteers
- 190 people
- Sponsor
- Valenta Pharm JSC
Helminth Infections
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.
- Trial name
- NCT02034162
- Testing
- Mebendazole
- Where
- 3 sites in Ethiopia, Rwanda
- Volunteers
- 295 people
- Sponsor
- Janssen Research & Development, LLC
Bipolar I Depression
Lurasidone Pediatric Bipolar Study
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
- Trial name
- Illuminate (NCT02046369)
- Testing
- Lurasidone
- Where
- 66 sites in United States, Bulgaria and 9 more
- Volunteers
- 350 people
- Sponsor
- Sumitomo Pharma America, Inc.
Peripheral Venous Catheterization
A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population.
- Trial name
- NCT02265380
- Testing
- Placement of IV catheter
- Where
- Finland
- Volunteers
- 188 people
- Sponsor
- Optomeditech Oy
Pompe Disease (Late-onset)
ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD
This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric…
- Trial name
- NCT03911505
- Testing
- Cipaglucosidase Alfa, Miglustat
- Where
- 17 sites in United States, Australia and 4 more
- Volunteers
- 21 people
- Sponsor
- Amicus Therapeutics
Migraine
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.
- Trial name
- NCT05156398
- Testing
- Rimegepant
- Where
- 93 sites in United States, Canada and 5 more
- Volunteers
- 640 people
- Sponsor
- Pfizer
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