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

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00349193
• Collaborator: (none)
• Enrollment: 306
• Arms: 3
• Duration (Months): 17

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing Remitting Multiple Sclerosis	Drug: laquinimod 0.3; Drug: laquinimod 0.6; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 306 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reduction of brain lesions in the last 4 months of the study [36 weeks]

Secondary Outcome Measures

1. Relapse rate [36 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00349193
• Other Study ID Numbers: LAQ/5062; 2004-003943-28
• First Posted: Jul 6, 2006
• Last Update Posted: Apr 8, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: Relapsing Remitting Multiple Sclerosis
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis

Study Results

No Results Posted as of Apr 8, 2011