A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod

April 7, 2011 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects

Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.

The duration of the current study is 36 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Willing and able to give written informed consent
  2. Confirmed MS diagnosis as defined by the McDonald criteria
  3. R-R MS disease course.
  4. At least one gadolinium-enhanced lesion on screening MRI
  5. Women of child-bearing potential must practice a reliable method of birth control.
  6. Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

  1. Subjects who suffer from any form of progressive MS.
  2. Any condition which the investigator feels may interfere with participation in the study.
  3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
  4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
  5. Previous treatment with immunomodulators within two months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laquinimod 0.3 mg
Drug: laquinimod 0.3
laquinimod 0.3mg
Active Comparator: Laquinimod 0.6 mg
Drug: laquinimod 0.6
laquinimod 0.6mg
Placebo Comparator: Placebo
Blinded Placebo
Other: Placebo
Blinded Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of brain lesions in the last 4 months of the study
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Relapse rate
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Chair: Prof. Giancarlo Comi, Teva Pharmaceutical Industries, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (Estimate)

July 6, 2006

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAQ/5062
  • 2004-003943-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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