Clinical Trial: Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Titration Proof of Concept Study in Patients With Huntington's Disease to Assess the Efficacy, Safety a
Brief Summary: This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize standard therapy in patients that have Huntington's disease in reducing chorea.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score. [ Time Frame: Baseline to day 28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [ Time Frame: Day 1 to day 46 ]
- Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients [ Time Frame: Day 1 to day 46 ]
Original Secondary Outcome:
- Safety and tolerability of AFQ056 in Huntington's disease patients [ Time Frame: Day 1 to day 46 ]
- Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [ Time Frame: Day 1 to day 46 ]
- Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients [ Time Frame: Day 1 to day 46 ]
Information By: Novartis
Dates:
Date Received: November 19, 2009
Date Started: November 2009
Date Completion:
Last Updated: September 22, 2011
Last Verified: September 2011