Clinical trials: Pediatric Safety and Effectiveness
Multiple Sclerosis, Relapsing-Remitting
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS.
- Trial name
- NCT03870763
- Testing
- Dimethyl Fumarate, Peginterferon Beta-1a
- Where
- 23 sites in United States, Colombia and 11 more
- Volunteers
- 11 people
- Sponsor
- Biogen
Hereditary Angioedema
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
- Trial name
- KONFIDENT-KID (NCT06467084)
- Testing
- KVD900 150 mg, KVD900 300 mg, KVD900 600 mg
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Ankle Sprain
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
- Trial name
- NCT01037816
- Testing
- FS-67 Patch
- Where
- 23 sites in United States
- Volunteers
- 252 people
- Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
Cerebral Palsy, Periventricular Leukomalacia
A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
- Trial name
- NCT04873752
- Testing
- UDI-001
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Rohto Pharmaceutical Co., Ltd.
Bowel Preparation
Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
Bowel preparation for pediatric colonoscopy.
- Trial name
- PICCOLO (NCT04113382)
- Testing
- CLENPIQ, MIRALAX, SENNA
- Where
- 4 sites in United States
- Volunteers
- 39 people
- Sponsor
- Ferring Pharmaceuticals
Viral Bronchiolitis
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.
- Trial name
- BRONKINOU (NCT00125450)
- Testing
- Chest Physiotherapy with Forced Expiratory Technique, Nasopharyngeal Aspiration
- Where
- 7 sites in France
- Volunteers
- 500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Down Syndrome, Cognitive Dysfunction
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, aged 11 to 17.
- Trial name
- NCT00754052
- Testing
- Aricept (donepezil hydrochloride)
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Baska Mask Efficacy and Safety in Children
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.
- Trial name
- NCT01625078
- Testing
- Placement and use of Baska mask
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- John Laffey
SCN2A-DEE, Epilepsy
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
- Trial name
- NCT05737784
- Testing
- PRAX-222 - Initial Dose, PRAX-222 - Initial Ascending Doses, PRAX-222 - Optional Ascending Doses
- Where
- 3 sites in United States, Brazil
- Volunteers
- 60 people
- Sponsor
- Praxis Precision Medicines
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Attention Deficit Hyperactivity Disorder (ADHD)
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard…
- Trial name
- NCT02618434
- Testing
- SPN-810 (18 mg), SPN-810 (36 mg)
- Where
- 32 sites in United States
- Volunteers
- 297 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Bladder, Neurogenic
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the…
- Trial name
- NCT00340704
- Testing
- tamsulosin hydrochloride
- Where
- 72 sites in United States, Belgium and 12 more
- Volunteers
- 143 people
- Sponsor
- Boehringer Ingelheim
Myopia, Myopia Progression
The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents.
- Trial name
- NCT06708156
- Testing
- Atropine sulfate eye drops 0.01%, Atropine sulfate eye drops 0.02%
- Where
- 25 sites in China
- Volunteers
- 606 people
- Sponsor
- Oupushifang Pharmaceutical Technology Co., Ltd.
Crohn Disease
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease.
- Trial name
- NCT02974322
- Testing
- GED-0301
- Where
- 311 sites in United States, Australia and 28 more
- Sponsor
- Celgene
Chalazion, Hordeolum
Pediatric Zylet Safety and Efficacy Study
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
- Trial name
- NCT00420628
- Testing
- loteprednol etabonate/tobramycin opthalmic suspension, vehicle
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Bausch & Lomb Incorporated
Immune Tolerance, Immunosuppression
Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
The goal of this clinical trial is to learn about the efficacy and safety of immunosuppressive withdrawal in pediatric liver transplant recipients.
- Conditions
- Immune Tolerance, Immunosuppression, Liver Transplant; Complications
- Trial name
- NCT06147375
- Testing
- Tacrolimus or Cyclosporine A
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Wei Gao
Central Nervous System Disease, Central Nervous System Neoplasms
Retrospective Study of MRI in Pediatric Patients
Collection of already existing data and images for patients < 2 years of age having MultiHance administration for a MRI of the brain or spine.
- Trial name
- NCT02291822
- Testing
- Gadobenate Dimeglumine
- Volunteers
- 90 people
- Sponsor
- Bracco Diagnostics, Inc
Intensive Care Unit, Postoperative Care
Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children
This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery.
- Trial name
- NCT04027829
- Testing
- Dexmedetomidine Hydrochloride
- Where
- South Korea
- Volunteers
- 13 people
- Sponsor
- Seoul National University Hospital
Adolescent Obesity, Obesity in Adolescence
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in…
- Conditions
- Adolescent Obesity, Obesity in Adolescence, Adolescent Overweight
- Trial name
- NCT03922945
- Testing
- VI-0521 oral capsule, Lifestyle Modification
- Where
- United States
- Volunteers
- 223 people
- Sponsor
- VIVUS LLC
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia…
- Trial name
- ZUMA-4 (NCT02625480)
- Testing
- Brexucabtagene Autoleucel (KTE-X19), Fludarabine, Cyclophosphamide
- Where
- 30 sites in United States, Belgium and 9 more
- Volunteers
- 95 people
- Sponsor
- Kite, A Gilead Company
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