Trial record 5 of 109 for:
First Time Use of SD-809 in Huntington Disease (First-HD)
This study is currently recruiting participants.
Verified April 2014 by Auspex Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Auspex Pharmaceuticals, Inc.
First received: February 20, 2013
Last updated: April 16, 2014
Last verified: April 2014
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Randomized Double Blind, Placebo Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Experimental: SD-809 ER Tablets
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: dutetrabenazine
Placebo Comparator: SD-809 Placebo
Placebo tablets are identical in appearance to SD-809 tablets.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
- 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.
- Subject has a Total Maximal Chorea Score (TMC) ≥ 8 at Screening and Baseline.
- Subject has a Total Functional Capacity (TFC) score ≥ 5 at Screening.
- Subject is able to swallow study medication whole.
- Subject has provided written, informed consent or, a legally authorized representative (LAR) has provided written informed consent and the subject has provided assent.
- Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
- 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.
- 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).
- Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
- Subject has active suicidal ideation at Screening or Baseline.
- Subject has history of suicidal behavior at Screening or Baseline:
- Subject has evidence for depression at Screening or Baseline.
- Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
- Subject has been recently exposed to tetrabenazine.
Subject has received any of the following concomitant medications within 30 days of Screening or Baseline:
- Monoamine oxidase inhibitors (MAOI)
- Levodopa or dopamine agonists
- Subject has significantly impaired swallowing function at Screening.
- Subject has significantly impaired speaking at Screening.
- Subject requires treatment with drugs known to prolong the QT interval.
- Subject has a prolonged QT interval on 12-lead ECG at Screening.
- Subject has evidence of hepatic impairment at Screening.
- Subject has evidence of significant renal impairment at Screening.
- Subject has known allergy to any of the components of study medication.
- Subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
- Subject is pregnant or breast-feeding at Screening or Baseline.
- Subject acknowledges present use of illicit drugs at Screening.
- Subject has a history of alcohol or substance abuse in the previous 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01795859
Auspex Pharmaceuticals, Inc.
No publications provided
||Auspex Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 20, 2013
||April 16, 2014
||United States: Food and Drug Administration
Keywords provided by Auspex Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Delirium, Dementia, Amnestic, Cognitive Disorders