Alternatives for Reducing Chorea in HD (ARC-HD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Auspex Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Auspex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01897896
First received: June 14, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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,


Condition Intervention Phase
Chorea Associated With Huntington Disease
Drug: SD-809
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Long Term Safety Study of SD-809 ER in Patients With Chorea Associated With Huntington Disease

Resource links provided by NLM:


Further study details as provided by Auspex Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal [ Time Frame: Up to 58 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 Week 54 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes from baseline in clinical laboratory parameters (hematology, chemistry and urinalysis) [ Time Frame: Up to 58 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in UHDRS, UPDRS (dysarthria), BARS, HADS, ESS, C-SSR, and MoCA [ Time Frame: Up to 58 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in vital signs [ Time Frame: Up to 58 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in ECG parameters and abnormal findings [ Time Frame: Up to 58 weeks ] [ Designated as safety issue: No ]
  • Duration of time to achieve stable dosing of SD-809 ER [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: July 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Switch Subject Cohort
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.
Drug: SD-809
SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.
Other Name: deutetrabenazine
Experimental: Rollover Subject Cohort
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.
Drug: SD-809
SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.
Other Name: deutetrabenazine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897896

Contacts
Contact: Huntington Study Group (HSG) 800-487-7671 info@hsglimited.org

  Show 29 Study Locations
Sponsors and Collaborators
Auspex Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Auspex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01897896     History of Changes
Other Study ID Numbers: SD-809-C-16
Study First Received: June 14, 2013
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Auspex Pharmaceuticals, Inc.:
Chorea
Huntington Disease

Additional relevant MeSH terms:
Huntington Disease
Chorea
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014