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| Sponsor: | Teva Pharmaceutical Industries |
|---|---|
| Information provided by: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00509145 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Laquinimod Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) |
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Laquinimod
Laquinimod 0.6 mg capsule, oral, once daily
Other Name: TV-5600
|
| Placebo Comparator: 2 |
Drug: Placebo
oral, once daily, capsule
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Siyu Liu, Vice President, North American Innovative Research & Development and Head of Global Clinical Operations, Teva Neuroscience |
| ClinicalTrials.gov Identifier: | NCT00509145 History of Changes |
| Other Study ID Numbers: | MS-LAQ-301, EUDRACT 2007-003226-19 |
| Study First Received: | July 27, 2007 |
| Last Updated: | January 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Relapsing Remitting |
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |