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First Time Use of SD-809 in Huntington Disease (First-HD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01795859
First received: February 20, 2013
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to determine whether SD-809 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Total Maximal Chorea Score (TMC) [ Time Frame: 12 weeks ]
    The change in Total Maximal Chorea Score (TMC) from Baseline (defined for each subject as the average of values from the Screening and Day 0 visits) to maintenance therapy (defined for each subject as the average of values from the Week 9 and Week 12 visits). The maximal chorea score is determined from Item 12 of Unified Huntington's Disease Rating Scale and quantifies chorea based on assessments of the face, bucco-orallingual area, trunk, and the four extremities. The total maximal chorea score is a sum of chorea scores in the seven body regions. The scale ranges from 0-28 with a decrease indicating improvement in chorea.


Secondary Outcome Measures:
  • Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ]
    A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved

  • Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) [ Time Frame: 12 weeks ]
    A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.

  • Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 [ Time Frame: 12 weeks ]
    Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  • Change in Berg Balance Test (BBT) [ Time Frame: Baseline, 12 weeks ]
    The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.


Enrollment: 90
Actual Study Start Date: August 5, 2013
Study Completion Date: December 5, 2014
Primary Completion Date: December 5, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SD-809 ER Tablets
SD-809 ER tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.
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 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). All are administered three times a day, with the 6 mg final dose is placebo.
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.

Detailed Description:
This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 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 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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Subject is able to swallow study medication whole.
  • 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).

Exclusion Criteria:

  • 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:

    • Antipsychotics
    • Metoclopramide
    • Monoamine oxidase inhibitors (MAOI)
    • Levodopa or dopamine agonists
    • Reserpine
    • Amantadine
    • Memantine
  • 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.
  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

  Show 43 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01795859     History of Changes
Other Study ID Numbers: SD-809-C-15
Study First Received: February 20, 2013
Results First Received: May 5, 2017
Last Updated: July 13, 2017

Keywords provided by Teva Pharmaceutical Industries:
Huntington disease
Chorea
Tetrabenazine

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
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2017