| January 8, 2008 |
| June 10, 2009 |
| April 2008 |
| June 2011 (final data collection date for primary outcome measure) |
| Relapse rate [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00605215 on ClinicalTrials.gov Archive Site |
| Accumulation of disability; other MRI endpoints [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
| Accumulation of disability
Other MRI endpoints [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
| |
| BRAVO Study: Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®) |
| 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. |
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®). |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Multiple Sclerosis |
- Drug: laquinimod
- Drug: placebo
- Drug: Interferon β-1a (Avonex®)
|
- Experimental: 0.6 mg Laquinimod oral once daily
- Placebo Comparator: oral placebo once daily
- Active Comparator: Interferon β-1a (Avonex®) 30 mcg IM once weekly
|
| |
| |
| Active, not recruiting |
| 1200 |
| November 2011 |
| June 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Willing and able to give written informed consent
- Confirmed MS diagnosis as defined by the McDonald criteria
- R-R MS disease course
- Subjects must be in a stable neurological condition and free of corticosteroid treatment
- Women of child-bearing potential must practice a reliable method of birth control
- Must understand the requirements of the study and agree to comply with the study protocol
Exclusion Criteria:
- Subjects who suffer from any form of progressive MS
- Any condition which the investigator feels may interfere with participation in the study
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
- Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
- Previous treatment with immunomodulators within two months prior to screening
- Pregnancy or breastfeeding
|
| Both |
| 18 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Israel, Italy, Latvia, Lithuania, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Turkey, Ukraine |
| |
| NCT00605215 |
| Siyu Liu, Senior Director of Pan Am Clinical Operations, Teva Neuroscience |
| MS-LAQ-302, EUDRACT 2007-005450-23 |
| Teva Pharmaceutical Industries |
|
| Principal Investigator: |
Douglas L. Vollmer |
St. Joseph's Hospital & Medical Center |
|
| Principal Investigator: |
Per S Sorensen |
Copenhagen Trial Unit, Center for Clinical Intervention Research |
|
|
| Teva Pharmaceutical Industries |
| June 2009 |