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BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)

NCT00605215 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1331

Last updated 2022-04-21

Study results available
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Summary

The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).

Conditions

Interventions

DRUG

Laquinimod

Laquinimod will be administered per dose and schedule specified in the arm description.

DRUG

Placebo

Placebo matching to laquinimod will be administered per schedule specified in the arm description.

DRUG

Avonex®

Avonex® will be administered per dose and schedule specified in the arm description.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, M.D. · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-24
Primary Completion
2011-06-10
Completion
2011-06-10

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • Georgia
  • Germany
  • Israel
  • Italy
  • Lithuania
  • North Macedonia
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00605215 on ClinicalTrials.gov