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