A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
Overview
- Phase
- Phase 3
- Intervention
- SD-809
- Conditions
- Chorea
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 90
- Locations
- 42
- Primary Endpoint
- Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
- •Subject has been diagnosed with manifest HD
- •Subject is able to swallow study medication whole.
- •Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
- •The subject has a reliable caregiver who interacts with the patient on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
- •Subject is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (i.e., walker, cane) is permitted during ambulation).
Exclusion Criteria
- •Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
- •Subject has active suicidal ideation at Screening or Baseline.
- •Subject has history of suicidal behavior at Screening or Baseline:
- •Subject has evidence for depression at Screening or Baseline.
- •Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
- •Subject has been recently exposed to tetrabenazine.
- •Subject has received any of the following concomitant medications within 30 days of Screening or Baseline:
- •Antipsychotics
- •Metoclopramide
- •Monoamine oxidase inhibitors (MAOI)
Arms & Interventions
SD-809 ER Tablets
SD-809 ER tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.
Intervention: SD-809
SD-809 ER Tablets
SD-809 ER tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.
Intervention: Placebo
SD-809 Tablets
SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.
Intervention: SD-809
SD-809 Tablets
SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
Time Frame: Screening, Day 0, Weeks 9, 12
Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea
Secondary Outcomes
- Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)(12 weeks)
- Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12(Baseline, 12 weeks)
- Change in Berg Balance Test (BBT)(Baseline, 12 weeks)
- Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)(12 weeks)