Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)
NCT00509145 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1106
Last updated 2021-11-02
Summary
Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).
Conditions
Interventions
- DRUG
-
Laquinimod
Laquinimod 0.6 mg capsule, oral, once daily
- OTHER
-
Placebo
oral, once daily, capsule
Sponsors & Collaborators
-
Teva Branded Pharmaceutical Products R&D, Inc.
lead INDUSTRY
Principal Investigators
-
Giancarlo Comi · U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-11-13
- Primary Completion
- 2010-11-08
- Completion
- 2010-11-08
Countries
- United States
- Austria
- Bulgaria
- Canada
- Czechia
- Estonia
- France
- Georgia
- Germany
- Hungary
- Israel
- Italy
- Latvia
- Lithuania
- Netherlands
- Poland
- Romania
- Russia
- Serbia
- Spain
- Sweden
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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