Clinical trials: Pediatric Population
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone)
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily.
- Conditions
- Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone), Endocrine System Diseases, Hormones
- Trial name
- NCT02781727
- Testing
- Once weekly subcutaneous injection of TransCon hGH, Once daily subcutaneous injection of Genotropin
- Where
- 53 sites in United States, Armenia and 12 more
- Volunteers
- 162 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
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.
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
Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity
A Study to Evaluate Pharmacokinetics, Safety and Tolerability After a Single Dose Administration of JNJ-31001074 in Pediatric Patients (12-17 Years) With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) after a single dose of JNJ-31001074.
- Trial name
- NCT00890292
- Testing
- JNJ-31001074
- Volunteers
- 18 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hyperammonemia, Methylmalonic Acidemia
An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics
To obtain short-term and long-term clinical safety information, in pediatric and adult patients with PA and MMA treated with Carbaglu®.
- Conditions
- Hyperammonemia, Methylmalonic Acidemia, Propionic Acidemia
- Trial name
- NCT05040178
- Testing
- Carglumic Acid
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- RECORDATI GROUP
Asthma
Fall Epidemic Viral Pediatric Study
Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s).
- Trial name
- NCT01192178
- Testing
- FLOVENT™ DISKUS™ 100 mcg BID, ADVAIR™ DISKUS™ 100/50 mcg BID
- Where
- 38 sites in United States
- Volunteers
- 339 people
- Sponsor
- GlaxoSmithKline
Autism Spectrum Disorder
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors.
- Trial name
- NCT05439616
- Testing
- Cariprazine
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 161 people
- Sponsor
- AbbVie
Yellow Fever Immunization
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and…
- Trial name
- NCT07103148
- Testing
- Yellow fever vaccine (live), Measles, combinations with mumps and rubella, live attenuated
- Where
- 15 sites in Honduras, Mexico and 1 more
- Volunteers
- 2,440 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hunter Syndrome
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India
The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome.
- Trial name
- NCT05058391
- Testing
- Elaprase
- Where
- 5 sites in India
- Volunteers
- 5 people
- Sponsor
- Takeda
Epilepsy
Pediatric Epilepsy Study
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
- Trial name
- NCT00050947
- Testing
- oxcarbazepine
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 94 people
- Sponsor
- Novartis Pharmaceuticals
Behçet Disease
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD)…
- Trial name
- BEAN (NCT04528082)
- Testing
- Apremilast
- Where
- 27 sites in France, Greece and 6 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Learning Disorder, Specific, Learning Disability
Examining the Effect of a Digital MD for Cognitive and Musical Training + Reduced Conventional SOC on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading and/or Written Expression Deficit vs a Control Group Receiving Conventional SOC.
Poppins-02 is a multicentric randomized non-inferiority study examining the effect of the digital medical device Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on…
- Conditions
- Learning Disorder, Specific, Learning Disability, Specific Learning Disorder, With Impairment in Reading, Dyslexia
- Trial name
- POPPINS-02 (NCT06592911)
- Testing
- Poppins Clinical
- Where
- 2 sites in France
- Volunteers
- 306 people
- Sponsor
- Poppins
Asthma
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
- Trial name
- NCT00943683
- Testing
- montelukast sodium
- Volunteers
- 256 people
- Sponsor
- Organon and Co
Anesthesia
CARE--Childhood Awareness and Recall Evaluation
The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general…
- Trial name
- NCT00308984
- Where
- 3 sites in United States
- Volunteers
- 1,784 people
- Sponsor
- Medtronic - MITG
Generalized Tonic Clonic Seizures
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo.
- Trial name
- NCT01747915
- Testing
- Pregabalin Dose Level 1, Pregabalin Dose Level 2
- Where
- 127 sites in United States, Austria and 24 more
- Volunteers
- 219 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Surgical Bleeding
Topical Raplixa for Surgical Bleeding in Children
The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.
- Trial name
- NCT02117349
- Testing
- Raplixa, Gelfoam, Rescue treatment
- Where
- 13 sites in United States
- Volunteers
- 55 people
- Sponsor
- Mallinckrodt
Restless Legs Syndrome
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system.
- Trial name
- NCT01495793
- Testing
- Rotigotine
- Where
- 12 sites in United States
- Volunteers
- 42 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Diabetes, Diabetes Mellitus, Type 1
Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
- Trial name
- NCT00071448
- Testing
- insulin human, insulin lispro, insulin aspart
- Where
- 76 sites in United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S