Oral Laquinimod Compared to Interferon β-1a for Multiple Sclerosis
Research type
Research Study
Full title
A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/day Or 1.2 mg/day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
IRAS ID
136720
Contact name
Gavin Giovannoni
Contact email
Sponsor organisation
Teva Pharmaceutical Industries, Ltd
Eudract number
2013-002082-19
Research summary
The present study is a multinational, multicentre, randomised, double-blind,
parallel-group, active-control (rater blinded) study to evaluate the efficacy, safety and tolerability of 2 doses of oral administration of Laquinimod compared to Interferon β-1a administered intra-muscularly once weekly in subjects with Relapsing Remitting Multiple Sclerosis.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 study the safety, efficacy and tolerability of 2 doses of oral laquinimod, (0.6mg/day or 1.2mg/day) with a once weekly intra-muscular injection of Interferon β-1a (Avonex®) for patients with RRMS. Laquinimod works within the brain, possibly by controlling certain cells that cause damage to brain tissue. In this way, it may result in a slower accumulation of disability over time.
The study will be carried out at approximately 135 hospitals with approximately 600 patients that will be invited to participate. The study is scheduled to last approximately 13 months, with a 12 month treatment period.
Eligible subjects will be randomised in a 2.5:2.5:1 ratio into 1 of the following treatment arms: Oral laquinimod 0.6mg; Oral laquinimod 1.2mg; intra-muscular Interferon β-1a (Avonex®) 30 μg.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0321
Date of REC Opinion
13 Nov 2013
REC opinion
Further Information Favourable Opinion