Clinical Trial: Alternatives for Reducing Chorea in HD

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

Official Title: An Open Label, Long Term Safety Study of SD-809 ER in Patients With Chorea Associated With Huntington Disease

Brief Summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SD-809 ER in subjects switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long term treatment with SD-809 ER will be assessed in "Switch" subjects as well as "Rollover" subjects completing a randomized, double blind, placebo controlled study of SD-809 ER,

Detailed Summary:
Sponsor: Auspex Pharmaceuticals, Inc.

Current Primary Outcome:

  • Overall incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal [ Time Frame: Duration of study ]
  • Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the titration period in Rollover subjects [ Time Frame: Up to 8 weeks ]
  • Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the dose adjustment period in Switch subjects [ Time Frame: Up to 4 weeks ]
  • Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during long term treatment [ Time Frame: From Week 3 to end of study ]


Original Primary Outcome:

  • Overall incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal [ Time Frame: Up to 58 weeks ]
  • Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the titration period in Rollover subjects [ Time Frame: Up to 8 weeks ]
  • Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the dose adjustment period in Switch subjects [ Time Frame: Up to 4 weeks ]
  • Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during long term treatment [ Time Frame: From Week 3 to Week 54 ]


Current Secondary Outcome:

  • Changes from baseline in clinical laboratory parameters (hematology, chemistry and urinalysis) [ Time Frame: Duration of study ]
  • Changes from baseline in UHDRS, UPDRS (dysarthria), BARS, HADS, ESS, C-SSR, and MoCA [ Time Frame: Duration of study ]
  • Changes from baseline in vital signs [ Time Frame: Duration of study ]
  • Changes from baseline in ECG parameters and abnormal findings [ Time Frame: Duration of study ]
  • Duration of time to achieve stable dosing of SD-809 ER [ Time Frame: Up to 4 weeks ]


Original Secondary Outcome:

  • Changes from baseline in clinical laboratory parameters (hematology, chemistry and urinalysis) [ Time Frame: Up to 58 weeks ]
  • Changes from baseline in UHDRS, UPDRS (dysarthria), BARS, HADS, ESS, C-SSR, and MoCA [ Time Frame: Up to 58 weeks ]
  • Changes from baseline in vital signs [ Time Frame: Up to 58 weeks ]
  • Changes from baseline in ECG parameters and abnormal findings [ Time Frame: Up to 58 weeks ]
  • Duration of time to achieve stable dosing of SD-809 ER [ Time Frame: Up to 4 weeks ]


Information By: Teva Pharmaceutical Industries

Dates:
Date Received: June 14, 2013
Date Started: November 2013
Date Completion: October 2017
Last Updated: December 1, 2016
Last Verified: December 2016