Trial record 1 of 2 for:    A Randomized, Double Blind, Placebo Controlled Study of SD-809 ER for the Treatment of Chorea Associated with Huntington’s Disease
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First Time Use of SD-809 in Huntington Disease (First-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:
NCT01795859
First received: February 20, 2013
Last updated: July 31, 2014
Last verified: July 2014

February 20, 2013
July 31, 2014
June 2013
August 2014   (final data collection date for primary outcome measure)
Total Maximal Chorea Score (TMC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Total Maximal Chorea Score (TMC) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01795859 on ClinicalTrials.gov Archive Site
  • Treatment Success at the end of therapy as measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Treatment success at the end of therapy based on Clinical Global Impression of Change (CGIC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Short Form 36 Health Survey (SF-36) Physical component summary score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Berg Balance Test (BBT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
First Time Use of SD-809 in Huntington Disease
A Randomized Double Blind, Placebo Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease

The purpose of this study is to determine whether SD-809 ER tablets are effective in the treatment of chorea associated with Huntington's Disease.

This is a randomized, double blind, placebo controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of SD-809 ER 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 ER and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chorea
  • 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).
    Other Name: deutetrabenazine
  • Drug: Placebo
    Placebo tablets are identical in appearance to SD-809 tablets.
  • Experimental: SD-809 ER Tablets
    Intervention: Drug: SD-809
  • Placebo Comparator: SD-809 Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
August 2015
August 2014   (final data collection date for primary outcome measure)

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 has a Total Maximal Chorea Score (TMC) ≥ 8 at Screening and Baseline.
  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. Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
  8. 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.
  9. 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:

  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 Screening or Baseline.
  5. Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
  6. Subject has been recently exposed to tetrabenazine.
  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
  8. Subject has significantly impaired swallowing function at Screening.
  9. Subject has significantly impaired speaking at Screening.
  10. Subject requires treatment with drugs known to prolong the QT interval.
  11. Subject has a 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 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.
  18. Subject has a history of alcohol or substance abuse in the previous 12 months.
Both
18 Years and older
No
Contact: Huntington Study Group (HSG) 800-487-7671 info@hsglimited.org
United States,   Canada
 
NCT01795859
SD-809-C-15
Yes
Auspex Pharmaceuticals, Inc.
Auspex Pharmaceuticals, Inc.
Not Provided
Not Provided
Auspex Pharmaceuticals, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP