First Time Use of SD-809 in Huntington Disease

Chorea Clinical Trial

— First-HD  

Official title:

A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795859
• Other study ID #: SD-809-C-15
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2013
• Last updated: August 22, 2017
• Start date: August 5, 2013
• Est. completion date: December 5, 2014

Study information

• Verified date: August 2017
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 5, 2014
• Est. primary completion date: December 5, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chorea
• Huntington Disease

Intervention

Drug:
• 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).
• Placebo
Placebo tablets are identical in appearance to SD-809 tablets.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12	Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea	Screening, Day 0, Weeks 9, 12
Secondary	Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)	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	12 weeks
Secondary	Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)	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.	12 weeks
Secondary	Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12	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.	Baseline, 12 weeks
Secondary	Change in Berg Balance Test (BBT)	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.	Baseline, 12 weeks