Clinical Trial: Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multi-center, North American, Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (Open-Hart)
Brief Summary: Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.
Detailed Summary:
Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.
Current Primary Outcome: Number of subjects with at least one adverse event [ Time Frame: On average 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score [ Time Frame: On average 2 years ]
Original Secondary Outcome: UHDRS Total Motor Score [ Time Frame: On average 2 years ]
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: February 28, 2011
Date Started: March 2011
Date Completion: May 2021
Last Updated: December 1, 2016
Last Verified: December 2016
