Status:
COMPLETED
First Time Use of SD-809 in Huntington Disease
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Chorea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01795859
Start Date
August 5 2013
End Date
December 5 2014
Last Update
September 20 2017
Active Locations (43)
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1
Teva Investigational Site 057
Birmingham, Alabama, United States
2
Teva Investigational Site 038
Phoenix, Arizona, United States
3
Teva Investigational Site 298
Fayetteville, Arkansas, United States
4
Teva Investigational Site 050
Los Angeles, California, United States