BRAVO Study: Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)

This study is ongoing, but not recruiting participants.

First Received: January 8, 2008 Last Updated: June 10, 2009 History of Changes

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	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 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.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta 1a ABR 215062 Interferons

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Relapse rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Accumulation of disability; other MRI endpoints [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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
1: Experimental 0.6 mg Laquinimod oral once daily	Drug: laquinimod 0.6 mg oral once daily for 24 months
2: Placebo Comparator oral placebo once daily	Drug: placebo oral placebo once daily for 24 months
3: Active Comparator 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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605215

Show 137 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Principal Investigator:	Douglas L. Vollmer	St. Joseph's Hospital & Medical Center
Principal Investigator:	Per S Sorensen	Copenhagen Trial Unit, Center for Clinical Intervention Research

More Information

No publications provided

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:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00605215 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Interferons
Adjuvants, Immunologic

Sclerosis
Antiviral Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 27, 2009