First Time Use of SD-809 in Huntington Disease

Phase 3

Completed

Conditions: Chorea

Interventions: Drug: SD-809
Drug: Placebo

Registration Number: NCT01795859

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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)
- Levodopa or dopamine agonists
- Reserpine
- Amantadine
- Memantine
Subject has significantly impaired swallowing function at Screening.
Subject has significantly impaired speaking at Screening.
Subject requires treatment with drugs known to prolong the QT interval.
Subject has a prolonged QT interval on 12-lead ECG at Screening.
Subject has evidence of hepatic impairment at Screening.
Subject has evidence of significant renal impairment at Screening.
Subject has known allergy to any of the components of study medication.
Subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
Subject is pregnant or breast-feeding at Screening or Baseline.
Subject acknowledges present use of illicit drugs at Screening.
Subject has a history of alcohol or substance abuse in the previous 12 months.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SD-809 Tablets	Placebo	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.
SD-809 ER Tablets	SD-809	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.
SD-809 ER Tablets	Placebo	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.
SD-809 Tablets	SD-809	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12	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 Outcome Measures

Name	Time	Method
Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)	12 weeks	A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
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 the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change in Berg Balance Test (BBT)	Baseline, 12 weeks	The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.
Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)	12 weeks	A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.

Trial Locations

Locations (42): Teva Investigational Site 032
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Atlanta, Georgia, United States
Teva Investigational Site 020
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Columbus, Ohio, United States
Teva Investigational Site 057
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Birmingham, Alabama, United States
Teva Investigational Site 038
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Phoenix, Arizona, United States
Teva Investigational Site 298
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Fayetteville, Arkansas, United States
Teva Investigational Site 050
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Los Angeles, California, United States
Teva Investigational Site 160
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Gainesville, Florida, United States
Teva Investigational Site 052
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Englewood, Colorado, United States
Teva Investigational Site 196
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Boca Raton, Florida, United States
Teva Investigational Site 024
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Iowa City, Iowa, United States
Teva Investigational Site 087
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Louisville, Kentucky, United States
Teva Investigational Site 040
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Boston, Massachusetts, United States
Teva Investigational Site 027
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Saint Louis, Missouri, United States
Teva Investigational Site 028
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Baltimore, Maryland, United States
Teva Investigational Site 328
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Camden, New Jersey, United States
Teva Investigational Site 119
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Durham, North Carolina, United States
Teva Investigational Site 002
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New York, New York, United States
Teva Investigational Site 037
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Albany, New York, United States
Teva Investigational Site 342
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Patchogue, New York, United States
Teva Investigational Site 089
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Cincinnati, Ohio, United States
Teva Investigational Site 093
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Toledo, Ohio, United States
Teva Investigational Site 341
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Tulsa, Oklahoma, United States
Teva Investigational Site 031
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Nashville, Tennessee, United States
Teva Investigational Site 100
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Salt Lake City, Utah, United States
Teva Investigational Site 137
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Burlington, Vermont, United States
Teva Investigational Site 104
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Milwaukee, Wisconsin, United States
Teva Investigational Site 098
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Montreal, Canada
Teva Investigational Site 144
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Kew Vic, Australia
Teva Investigational Site 220
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Kirkland, Washington, United States
Teva Investigational Site 054
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Sydney, Australia
Teva Investigational Site 231
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Ottawa, Canada
Teva Investigational Site 300
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Ottawa, Canada
Teva Investigational Site 014
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Miami, Florida, United States
Teva Investigational Site 045
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Indianapolis, Indiana, United States
Teva Investigational Site 199
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Houston, Texas, United States
Teva Investigational Site 194
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Las Vegas, Nevada, United States
Teva Investigational Site 007
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Houston, Texas, United States
Teva Investigational Site 096
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Seattle, Washington, United States
Teva Investigational Site 083
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Wichita, Kansas, United States
Teva Investigational Site 029
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Kansas City, Kansas, United States
Teva Investigational Site 333
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Washington, D.C., District of Columbia, United States
Teva Investigational Site 026
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New Brunswick, New Jersey, United States