Clinical Trial: A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6

Brief Summary: This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.

Detailed Summary:
Sponsor: Teva Pharmaceutical Industries

Current Primary Outcome: Percent brain volume change (PBVC) [ Time Frame: 48 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to confirmed disability progression (CDP) [ Time Frame: 48 weeks ]
    Time to event
  • Change from baseline in timed 25 foot walk [ Time Frame: Baseline, Week 48 ]
  • Number of new T2 brain lesions [ Time Frame: 48 weeks ]


Original Secondary Outcome:

  • Time to confirmed disability progression (CDP) [ Time Frame: 48 weeks ]
    Time to event
  • Number of new T2 brain lesions [ Time Frame: 48 weeks ]
  • Change in the Brief International Cognitive Assessment for Multiple Sclerosis score (BICAMS) [ Time Frame: 48 weeks ]


Information By: Teva Pharmaceutical Industries

Dates:
Date Received: October 31, 2014
Date Started: January 2015
Date Completion: October 2017
Last Updated: December 1, 2016
Last Verified: December 2016