NCT00349193

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

Completed Phase 2 Last updated 7 April 2011

What this trial tests

Phase 2 trial testing laquinimod 0.3 in Relapsing Remitting Multiple Sclerosis in 306 participants. Completed in 1 August 2006.

Timeline

1 March 2005

Primary endpoint
1 June 2006

1 August 2006

Quick facts

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	306
Start date	1 March 2005
Primary completion	1 June 2006
Estimated completion	1 August 2006

Drugs / interventions tested

• laquinimod 0.3 — full drug profile →
• laquinimod 0.6 — full drug profile →
• Placebo

Conditions studied

• Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. — full company profile →

Who can join

Adults 18 to 50, any sex, with Relapsing Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Reduction of brain lesions in the last 4 months of the study
  Time frame: 36 weeks

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study.
   Comi G, Pulizzi A, Rovaris M, Abramsky O, et al · · 2008 · cited 185× · PMID 18572078 · DOI 10.1016/s0140-6736(08)60918-6
2. Laquinimod therapy in multiple sclerosis: a comprehensive review.
   Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. · · 2014 · cited 10× · PMID 26000222 · DOI 10.1007/s40120-014-0017-6
3. Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
   Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
4. Laquinimod for multiple sclerosis.
   He D, Han K, Gao X, Dong S, et al · · 2013 · cited 2× · PMID 23922214 · DOI 10.1002/14651858.cd010475.pub2
5. Efficacy and safety of disease-modifying oral drugs in treatment of relapsing-remitting multiple sclerosis: systematic review and network meta-analysis.
   Zhao Y, Chen B, Zhao X, Yang R, et al · · 2026 · PMID 41918730 · DOI 10.3389/fimmu.2026.1733948