TERIKIDS
Research type
Research Study
Full title
A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of Teriflunomide administered orally once daily in Pediatric patients with Relapsing forms of Multiple Sclerosis followed by an Open-Label extension.
IRAS ID
148628
Contact name
Ming Lim
Contact email
Sponsor organisation
Genzyme Corporation
Eudract number
2011-005249-12
Clinicaltrials.gov Identifier
067476, IND
Research summary
Multiple Sclerosis (MS) is a neurological disease which commonly affects patients between 20 to 40 years of age. However, pediatric MS, defined as onset of MS before the age of 16, is increasingly recognised and is thought to account for approximately 5 percent of cases.
Multiple Sclerosis in children and differences from the common adult form of MS to a large extent are understudied. There are no approved disease modifying drugs for pediatric MS and the effects of drugs in children have not been formally evaluated in clinical trials.
Teriflunomide has demonstrated advantages in adult relapsing forms of MS patients in reducing frequency of relapse rate, disease progression, and MRI activity.
The objectives of the proposed clinical pediatric development program are to assess the efficacy, safety/tolerability, and pharmacokinetics (PK) of teriflunomide in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis (RMS).REC name
London - Central Research Ethics Committee
REC reference
14/LO/1407
Date of REC Opinion
29 Sep 2014
REC opinion
Further Information Favourable Opinion