Clinical Trial: Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy
Brief Summary: The purpose of the study is to evaluate the safety and efficacy of davunetide for the treatment of Progressive Supranuclear Palsy.
Detailed Summary: A Phase 2/3,Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy
Sponsor: Allon Therapeutics
Current Primary Outcome:
- Efficacy, as measured by change from baseline scores of the Progressive Supranuclear Palsy Rating Scale (PSPRS) at 52 weeks [ Time Frame: 52 weeks ]
- Efficacy, as measured by the change from baseline of the Schwab and England Activities of Daily Living Scale (SEADL) at 52 weeks [ Time Frame: 52 weeks ]
- Safety, as measured by reported AEs, electrocardiograms (ECG), nasal examinations and clinical laboratory measures [ Time Frame: 52 weeks ]
Original Primary Outcome:
- Change from baseline scores of the Progressive Supranuclear Palsy Rating Scale (PSPRS) [ Time Frame: 52 weeks ]
- Safety, as measured by reported adverse events (AEs), electrocardiograms (ECGs), and clinical laboratory measures [ Time Frame: 6, 13, 26, 39, 52 weeks ]
Current Secondary Outcome:
- Efficacy, as measured by the Clinical Global Impression of Change (CGI-C) at 52 weeks [ Time Frame: 52 weeks ]
- Brain atrophy, as measured by change from baseline of ventricular volumes measured by volumetric brain MRI at 52 weeks. [ Time Frame: 52 weeks ]
Original Secondary Outcome:
- Change from baseline of the Schwab and England Activities of Daily Living Scale (SEADL) [ Time Frame: 52 weeks ]
- Change from baseline of the Clinical Global Impression of Disease Severity (CGI ds) [ Time Frame: 52 weeks. ]
- Brain atrophy, as measured by change from baseline of ventricular volumes measured by volumetric brain magnetic resonance imaging (MRI) [ Time Frame: 52 weeks ]
Information By: Allon Therapeutics
Dates:
Date Received: April 23, 2010
Date Started: October 2010
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013