Clinical Trial: Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112 Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112, a GSK-3 Inhibitor, Versus Placebo in the
Brief Summary: The purpose of this study is to determine wether NP031112 is safe and effective in the treatment of mild to moderate Progressive Supranuclear Palsy
Detailed Summary:
Sponsor: Noscira SA
Current Primary Outcome: The change from Baseline between the 2 active study medication groups compared with the placebo group in the Progressive Supranuclear Palsy Rating Scale of Golbe [ Time Frame: 52 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of AEs and patients with an incidence rate of ≥ 5% AEs [ Time Frame: 52 weeks ]
- Change from Baseline between 2 active study medication groups vs placebo group in Modified Schwab and England Scale [ Time Frame: 52 weeks ]
- Change from Baseline between 2 active study medication groups vs placebo group in Timed Up and Go Test (quantitative motor function) [ Time Frame: 52 weeks ]
- Change from Baseline between 2 active study medication groups vs placebo group in cognitive function(Dementia Rating Scale-2,Frontal Assessment Battery,category and letter verbal fluency) [ Time Frame: 52 weeks ]
- Change from Baseline between 2 active study medication groups vs placebo group in Starkstein Apathy Scale (behavior) [ Time Frame: 52 weeks ]
- Change from Baseline between 2 active study medication groups vs placebo group in functional assessments(Unified Parkinson Disease rating Scale part II and European Quality of Life questionnaire) [ Time Frame: 52 weeks ]
- Change from Baseline between 2 active study medication groups vs placebo group in Clinical Global Impression of Change [ Time Frame: 52 weeks ]
- Change from Baseline between 2 active study medication groups vs placebo group in Clinical Global Impression of Severity [ Time Frame: 52 weeks ]
Original Secondary Outcome: Same as current
Information By: Noscira SA
Dates:
Date Received: January 13, 2010
Date Started: December 2009
Date Completion:
Last Updated: January 2, 2012
Last Verified: January 2012