Status:
COMPLETED
Alternatives for Reducing Chorea in Huntington Disease
Lead Sponsor:
Auspex Pharmaceuticals, Inc.
Conditions:
Chorea Associated With Huntington Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safe...
Eligibility Criteria
Inclusion
- Participant is at least 18 years of age or the age of majority (whichever is older) at Screening.
- Participant has been diagnosed with manifest HD, as indicated by characteristic motor exam features, and has a documented expanded cytosine adenine guanine (CAG) repeat (greater than or equal to \>= \[37\]) at or before Screening.
- Participant meets either of the following:
- Has successfully completed participation in the First-HD Study (SD-809-C-15) or
- Has been receiving an Food and Drug Administration (FDA)-approved dose of tetrabenazine that has been stable for \>=8 weeks before Screening and is providing a therapeutic benefit for control of chorea.
- Participant has a Total Functional Capacity (TFC) score \>=5 at Screening.
- Participant is able to swallow study medication whole.
- Participant has provided written, informed consent or, a legally authorized representative (LAR) has provided written informed consent and the subject has provided assent.
- Participant has provided a Research Advance Directive.
- Female participants of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
- The participant has a reliable caregiver who interacts with the participant on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
- Participant is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (such as; walker, cane) are permitted during ambulation).
- Has sufficient reading skills to comprehend the participant completed rating scales.
Exclusion
- Participant has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
- Participant has active suicidal ideation at Screening or Baseline.
- Participant has history of suicidal behavior at Screening or Baseline.
- Participant has evidence for depression at Baseline.
- Participant has an unstable or serious medical illness at Screening or Baseline.
- Participant has received tetrabenazine within 7 days of Baseline (Rollover participants only).
- Participant 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 (Rollover participants only)
- Switch participants may receive Memantine if on a stable, approved dose for at least 30 days
- Participant has significantly impaired swallowing function at Screening or Baseline.
- Participant has significantly impaired speaking at Screening or Baseline.
- Participant requires treatment with drugs known to prolong the QT interval.
- Participant has prolonged QT interval on 12-lead electrocardiogram (ECG) at Screening.
- Participant has evidence of hepatic impairment at Screening.
- Participant has evidence of significant renal impairment at Screening.
- Participant has known allergy to any of the components of study medication.
- Participant has participated in an investigational drug or device trial other than SD-809-C-15 within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
- Participant is pregnant or breast-feeding at Screening or Baseline.
- Participant acknowledges present use of illicit drugs at Screening or Baseline.
- Participant has a history of alcohol or substance abuse in the previous 12 months.
Key Trial Info
Start Date :
November 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2017
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01897896
Start Date
November 12 2013
End Date
August 21 2017
Last Update
November 9 2021
Active Locations (38)
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1
Teva Investigational Site 057
Birmingham, Alabama, United States, 35233
2
Teva Investigational Site 038
Phoenix, Arizona, United States, 85013
3
Teva Investigational Site 298
Fayetteville, Arkansas, United States, 72703
4
Teva Investigational Site 052
Englewood, Colorado, United States, 80113