Clinical trials: Pediatric Multiple Sclerosis
Multiple Sclerosis
Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.
- Trial name
- NCT02137109
- Testing
- natalizumab
- Volunteers
- 400 people
- Sponsor
- Biogen
Relapsing Forms of Multiple Sclerosis
A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses.
- Trial name
- VOYAGE (NCT07483632)
- Testing
- Diroximel Fumarate, Dimethyl Fumarate, Fingolimod
- Volunteers
- 185 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200).
- Trial name
- NCT02555215
- Testing
- dimethyl fumarate
- Where
- 12 sites in United States, Belgium and 8 more
- Volunteers
- 20 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric…
- Trial name
- NCT03958877
- Testing
- BIIB017 (peginterferon beta-1a), Interferon beta type 1a
- Where
- 65 sites in United States, Argentina and 20 more
- Volunteers
- 152 people
- Sponsor
- Biogen
Multiple Sclerosis
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)
- Trial name
- NCT01892722
- Testing
- Interferon beta-1a, Fingolimod
- Where
- 73 sites in United States, Australia and 23 more
- Volunteers
- 240 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)
The aim of this retrospective study is to review and describe safety, tolerability and efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using information already recorded in medical records.
- Trial name
- REPLAY (NCT01207648)
- Testing
- Rebif®
- Where
- 18 sites in United States, Argentina and 6 more
- Volunteers
- 307 people
- Sponsor
- EMD Serono
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
Multiple Sclerosis
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Primary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing…
- Trial name
- TERIKIDS (NCT02201108)
- Testing
- Teriflunomide
- Where
- 57 sites in United States, Belgium and 20 more
- Volunteers
- 166 people
- Sponsor
- Genzyme, a Sanofi Company
Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT02428218
- Testing
- dimethyl fumarate
- Sponsor
- Biogen
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Multiple Sclerosis (MS)
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
- Trial name
- NEOS (NCT04926818)
- Testing
- Fingolimod, Ofatumumab, Siponimod
- Where
- 51 sites in United States, Argentina and 23 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing-remitting Multiple Sclerosis
A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and < 18 years over a flexible duration.
- Trial name
- Operetta 2 (NCT05123703)
- Testing
- Ocrelizumab, Fingolimod
- Where
- 71 sites in United States, Argentina and 23 more
- Volunteers
- 188 people
- Sponsor
- Hoffmann-La Roche
Relapsing-Remitting Multiple Sclerosis
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT01884935
- Testing
- Natalizumab
- Where
- 5 sites in Italy
- Volunteers
- 13 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and…
- Trial name
- CONNECT (NCT02283853)
- Testing
- dimethyl fumarate, Interferon β-1a
- Where
- 62 sites in United States, Belgium and 16 more
- Volunteers
- 156 people
- Sponsor
- Biogen
Relapsing Multiple Sclerosis
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and < 18 years.
- Trial name
- FENerations1 (NCT07161258)
- Testing
- Fenebrutinib
- Where
- 17 sites in Argentina, Brazil and 5 more
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis, Relapsing-Remitting
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- FOCUS (NCT02410200)
- Testing
- dimethyl fumarate
- Where
- 12 sites in United States, Belgium and 8 more
- Volunteers
- 22 people
- Sponsor
- Biogen
Relapsing Multiple Sclerosis
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to…
- Trial name
- NCT07220252
- Testing
- Ublituximab, Fingolimod
- Where
- 3 sites in Poland
- Volunteers
- 240 people
- Sponsor
- TG Therapeutics, Inc.
Multiple Sclerosis
A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who…
- Trial name
- LemKids (NCT03368664)
- Testing
- Alemtuzumab GZ402673, Glatiramer acetate, Beta-Interferon
- Where
- 13 sites in France, Italy and 4 more
- Volunteers
- 16 people
- Sponsor
- Genzyme, a Sanofi Company
Relapsing Multiple Sclerosis (RMS)
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
The main purpose of this study was to assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing multiple sclerosis (RMS)
- Trial name
- NCT04667949
- Testing
- Fingolimod 0.5mg
- Where
- 13 sites in China
- Volunteers
- 98 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years.
- Trial name
- NCT00963833
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Where
- 6 sites in Austria, Belgium and 4 more
- Volunteers
- 68 people
- Sponsor
- Bayer