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| Sponsor: | Teva Pharmaceutical Industries |
|---|---|
| Information provided by (Responsible Party): | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00605215 |
Purpose
The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 mg with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing MS injectable drug: Interferon β-1a (Avonex®).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: laquinimod Drug: placebo Drug: Interferon β-1a (Avonex®) |
Phase 3 |
| 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: | A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With RRMS to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design. |
| Enrollment: | 1331 |
| Study Start Date: | April 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Laquinimod
0.6 mg Laquinimod oral once daily
|
Drug: laquinimod
0.6 mg oral once daily for 24 months
|
|
Placebo Comparator: Placebo
oral placebo once daily
|
Drug: placebo
oral placebo once daily for 24 months
|
|
Active Comparator: Interferon
Interferon β-1a (Avonex®) 30 mcg IM once weekly
|
Drug: Interferon β-1a (Avonex®)
Interferon β-1a (Avonex®) 30 mcg IM once weekly for 24 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
a. Exclusion Criteria:
Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:
Exclusion Criteria:
Contacts and Locations
Show 148 Study Locations| Principal Investigator: | Timothy L. Vollmer | St. Joseph's Hospital & Medical Center |
More Information
| Responsible Party: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00605215 History of Changes |
| Other Study ID Numbers: | MS-LAQ-302, EUDRACT 2007-005450-23 |
| Study First Received: | January 8, 2008 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration Austria : Federal Ministry for Labour, Health, and Social Affairs Bulgaria: Bulgarian Drug Agency Canada: Health Canada Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine European Union: European Medicines Agency France: Ministry of Health Georgia: Ministry of Health Germany: Ministry of Health Hungary: National Institute of Pharmacy Israel: Ministry of Health Italy: Ministry of Health Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Poland: Ministry of Health Romania: Ministry of Public Health Russia: Ministry of Health and Social Development of the Russian Federation Bulgaria: Ministry of Health Spain: Ministry of Health Sweden: Medical Products Agency Turkey: Ministry of Health Ukraine: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon beta 1a |
Interferons Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |