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