An Open Label Extension of the LAQ/5062 and LAQ/5063 Studies to Assess the Long Term Safety and Tolerability of Laquinimod 0.6mg in RRMS Patients
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- long-term safety and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 1
0.6 mg laquinimod once daily
0.6 mg, oral, once daily
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|Principal Investigator:||Giancarlo Comi||Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy|