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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00605215 |
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 |
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Multiple Sclerosis |
Drug: laquinimod Drug: placebo Drug: Interferon β-1a (Avonex®) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 1200 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
0.6 mg Laquinimod oral once daily
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Drug: laquinimod
0.6 mg oral once daily for 24 months
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2: Placebo Comparator
oral placebo once daily
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Drug: placebo
oral placebo once daily for 24 months
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3: Active Comparator
Interferon β-1a (Avonex®) 30 mcg IM once weekly
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Drug: Interferon β-1a (Avonex®)
Interferon β-1a (Avonex®) 30 mcg IM once weekly for 24 months
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dan Bar-Zohar | 972-9-8631970 | |
Contact: David Kormann | 215-293-6309 |
Principal Investigator: | Douglas L. Vollmer | St. Joseph's Hospital & Medical Center |
Principal Investigator: | Per S Sorensen | Copenhagen Trial Unit, Center for Clinical Intervention Research |
Responsible Party: | Teva Neuroscience ( Siyu Liu, Senior Director of Pan Am Clinical Operations ) |
Study ID Numbers: | MS-LAQ-302, EUDRACT 2007-005450-23 |
Study First Received: | January 8, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00605215 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon-beta |
Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |