Conditions: Multiple Sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1331
Healthy volunteers: no

Brief summary:
The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).

Detailed description:

Arms:
arm 1: Participants will receive 1 capsule of placebo matching to laquinimod orally once daily for 24 months. arm 2: Participants will receive 1 capsule of laquinimod 0.6 mg orally once daily for 24 months. arm 3: Participants will receive an injection of Avonex® 30 micrograms (mcg) given intramuscularly (IM) once weekly for 24 months.

Interventions: intervention 1: Laquinimod intervention 2: Placebo intervention 3: Avonex®
Intervention descriptions: intervention 1: Laquinimod will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to laquinimod will be administered per schedule specified in the arm description. intervention 3: Avonex® will be administered per dose and schedule specified in the arm description.

Protocol document: