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
  Purpose

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.


Condition Intervention Phase
Chorea
Drug: SD-809
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind, Placebo Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Total Maximal Chorea Score (TMC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SD-809 ER Tablets 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
Placebo Comparator: SD-809 Placebo Drug: Placebo
Placebo tablets are identical in appearance to SD-809 tablets.

Detailed Description:

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.

  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 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.
  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: NCT01795859

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

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35233
United States, Arkansas
Withdrawn
Fayetteville, Arkansas, United States, 72703
United States, California
Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
Recruiting
Englewood, Colorado, United States, 80113
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Recruiting
Boca Raton, Florida, United States, 33486
Recruiting
Gainesville, Florida, United States, 32607
Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30329
United States, Indiana
Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Recruiting
Kansas City, Kansas, United States, 66160
Recruiting
Wichita, Kansas, United States, 67226
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02118
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Recruiting
Camden, New Jersey, United States, 08103
Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Recruiting
Albany, New York, United States, 12208
Recruiting
New York, New York, United States, 10032
Recruiting
Patchogue, New York, United States, 11772
United States, North Carolina
Recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45267
Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States, 71436
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Recruiting
Houston, Texas, United States, 77030
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84108
United States, Vermont
Recruiting
Burlington, Vermont, United States, 05401
United States, Washington
Recruiting
Kirkland, Washington, United States, 98034
Recruiting
Seattle, Washington, United States, 98195
United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Recruiting
Ottawa, Ontario, Canada, K1G 4G3
Recruiting
Toronto, Ontario, Canada, M2K 1E1
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Auspex Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Auspex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01795859     History of Changes
Other Study ID Numbers: SD-809-C-15
Study First Received: February 20, 2013
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Auspex Pharmaceuticals, Inc.:
Huntington disease
Chorea
Tetrabenazine

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

ClinicalTrials.gov processed this record on September 11, 2014