Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 1:05 AM
Study NCT ID:
NCT01795859
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
First Time Use of SD-809 in Huntington Disease
Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Organization:
Study Overview
Official Title:
A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
First-HD
Brief Summary:
The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.
Detailed Description:
This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 for the treatment of chorea associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving SD-809 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: