Study of Oral Laquinimod in Subjects with Multiple Sclerosis
Research type
Research Study
Full title
A multinational, multicenter, randomized, double-blind, parallel-group, placebo controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS).
IRAS ID
115760
Contact name
Carolyn Young
Sponsor organisation
Teva Pharmaceutical Industries, Ltd.
Eudract number
2012-003647-30
Clinicaltrials.gov Identifier
Research summary
The present study is a multinational, multicentre, randomised, double-blind, parallel-group, placebo-controlled study (Period 1), followed by an active treatment period (Period 2), to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod (0.6 mg or 1.2 mg) compared to placebo in Relapsing Remitting Multiple Sclerosis (RRMS) patients. Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms and often progresses to physical and cognitive disability. There is no known cure for multiple sclerosis. Treatments attempt to return function after an attack, prevent new attacks, and prevent disability. MS medications can have adverse effects or be poorly tolerated, and many people pursue alternative treatments. The purpose of this study is to compare two doses, 0.6 mg and 1.2 mg, of an investigational product, laquinimod, to placebo for patients with RRMS. The study will be carried out at approximately 300 hospitals with approximately 1,800 patients that will be invited to participate. Doctors in the Neurological Departments of NHS hospitals will be treating participants in the UK. The study is scheduled to last up to 49 months and will consist of two Periods: Period 1 which is a double-blind placebo-controlled period lasting 15-24 months and Period 2 which is an active treatment period lasting 24 months. Eligible patients will be randomly assigned to receive either 0.6mg, 1.2mg of laquinimod or placebo in Period 1 of the study. There is a 33% chance of receiving placebo in Period 1. In Period 2, all participants will be assigned daily oral laquinimod.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
12/NW/0802
Date of REC Opinion
20 Dec 2012
REC opinion
Further Information Favourable Opinion