This trial is active, not recruiting.

Condition relapsing remitting multiple sclerosis
Treatment laquinimod
Phase phase 2
Sponsor Teva Pharmaceutical Industries
Start date December 2006
End date December 2018
Trial size 211 participants
Trial identifier NCT00745615, EUDRACT 2005-004334-41, LAQ/5063OL


This is a continuation of the LAQ/5063 study which was a multinational, multicenter, randomized, double-blind, parallel group study, assessing the safety, tolerability and efficacy of two doses of laquinimod in subjects with R-R MS followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).

Subjects entering this randomized, two active arms study immediately after completion of the LAQ/5062 core study.

Subjects entering the open-label phase (LAQ/5063 OL) upon the termination visit of LAQ/5063 active double-blind phase

Subjects previously treated with placebo in the LAQ/5062 study are equally randomized to one of the active treatment groups:

0.6 mg of laquinimod per os (p.o.) once daily 0.3 mg of laquinimod p.o. once daily Subjects previously treated with laquinimod 0.6 mg or laquinimod 0.3 mg continuing on their original treatment assignment.

The LAQ/5063 study assessed the 0.3mg and the 0.6mg daily doses of laquinimod in patients who completed the LAQ/5062 study.

Upon the termination visit of LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor) and after meeting the eligibility criteria of the open-label phase, all subjects began treatment with laquinimod 0.6 mg once daily for 24 months In the current phase, this open-label extension is further extended in additional 36 months of treatment with laquinimod 0.6mg once daily.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
0.6 mg laquinimod once daily
0.6 mg, oral, once daily

Primary Outcomes

long-term safety and tolerability
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria - For the 36 months further extension: Subjects must have completed the 24 months of treatment of the first period of the open label phase - Women of child-bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control.) Exclusion Criteria - For the 36 month further extension: Premature discontinuation from Laq/5063 OL phase prior to completion of 24 months of treatment period - pregnancy or breast feeding

Additional Information

Official title [An Active Extension of LAQ/5062 Study. A Multinational, Multi-center, Randomized, Double-blind, Parallel-group Study, to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3mg and 0.6mg) of Laquinimod,] Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects Followed by an Open Label Phase of Laquinimod 0.6 mg Daily.
Principal investigator Giancarlo Comi
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.