Overview

This trial is active, not recruiting.

Condition chorea associated with huntington disease
Treatment sd-809
Phase phase 3
Sponsor Auspex Pharmaceuticals, Inc.
Start date November 2013
End date July 2017
Trial size 238 participants
Trial identifier NCT01897896, SD-809-C-16

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SD-809 ER in subjects switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long term treatment with SD-809 ER will be assessed in "Switch" subjects as well as "Rollover" subjects completing a randomized, double blind, placebo controlled study of SD-809 ER,

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Switch subjects are those who are currently receiving stable doses of tetrabenazine for treatment of chorea associated with HD and convert to SD-809 ER based on an algorithm designed to achieve comparable exposure to total (α+β)-HTBZ metabolites.
sd-809 deutetrabenazine
SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.
(Experimental)
Rollover subjects are those who have successfully completed Study SD-809-C-15 and are continuing on long-term SD-809 ER after a 1-week wash out period.
sd-809 deutetrabenazine
SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.

Primary Outcomes

Measure
Overall incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal
time frame: Duration of study
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the titration period in Rollover subjects
time frame: Up to 8 weeks
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the dose adjustment period in Switch subjects
time frame: Up to 4 weeks
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during long term treatment
time frame: From Week 3 to end of study

Secondary Outcomes

Measure
Changes from baseline in clinical laboratory parameters (hematology, chemistry and urinalysis)
time frame: Duration of study
Changes from baseline in UHDRS, UPDRS (dysarthria), BARS, HADS, ESS, C-SSR, and MoCA
time frame: Duration of study
Changes from baseline in vital signs
time frame: Duration of study
Changes from baseline in ECG parameters and abnormal findings
time frame: Duration of study
Duration of time to achieve stable dosing of SD-809 ER
time frame: Up to 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subject is at least 18 years of age or the age of majority (whichever is older) at Screening. 2. Subject has been diagnosed with manifest HD, as indicated by characteristic motor exam features, and has a documented expanded CAG repeat (≥ 37) at or before Screening. 3. Subject meets either of the following: - Has successfully completed participation in the First-HD Study (SD-809-C-15) OR - Has been receiving an FDA-approved dose of tetrabenazine that has been stable for ≥ 8 weeks before Screening and is providing a therapeutic benefit for control of chorea. 4. Subject has a Total Functional Capacity (TFC) score ≥ 5 at Screening. 5. Subject is able to swallow study medication whole. 6. Subject has provided written, informed consent or, a legally authorized representative (LAR) has provided written informed consent and the subject has provided assent. 7. Subject has provided a Research Advance Directive. 8. Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion. 9. 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. 10. Subject is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (i.e., walker, cane) are permitted during ambulation). 11. Has sufficient reading skills to comprehend the subject completed rating scales. Exclusion Criteria: 1. Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline. 2. Subject has active suicidal ideation at Screening or Baseline. 3. Subject has history of suicidal behavior at Screening or Baseline. 4. Subject has evidence for depression at Baseline. 5. Subject has an unstable or serious medical illness at Screening or Baseline. 6. Subject has received tetrabenazine within 7 days of Baseline (Rollover subjects only). 7. 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 (Rollover subjects only) - Switch subjects may receive Memantine if on a stable, approved dose for at least 30 days 8. Subject has significantly impaired swallowing function at Screening or Baseline. 9. Subject has significantly impaired speaking at Screening or Baseline. 10. Subject requires treatment with drugs known to prolong the QT interval. 11. Subject has prolonged QT interval on 12-lead ECG at Screening. 12. Subject has evidence of hepatic impairment at Screening. 13. Subject has evidence of significant renal impairment at Screening. 14. Subject has known allergy to any of the components of study medication. 15. Subject 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. 16. Subject is pregnant or breast-feeding at Screening or Baseline. 17. Subject acknowledges present use of illicit drugs at Screening or Baseline. 18. Subject has a history of alcohol or substance abuse in the previous 12 months.

Additional Information

Official title An Open Label, Long Term Safety Study of SD-809 ER in Patients With Chorea Associated With Huntington Disease
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.