WHO ICTRP trial
Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the…
EUCTR2018-000516-22-HU · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-000516-22-HU |
|---|---|
| Public title | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants |
| Scientific title | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis |
| Primary sponsor | Biogen Idec Research Limited |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of |
| Conditions | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification… |
| Interventions | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: DIMETHYL FUMARATE CAS Number: 624-49-7 Current Sponsor code: BG00012 Other descriptive name: DIMETHYL… |
| Registration date | Feb 1, 2019 |
| Target size | 340 |
| Secondary IDs | 800MS301;2018-000516-22-PT |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: