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

August 22, 2017 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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 tablets are effective in the treatment of chorea associated with Huntington's Disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Kew Vic, Australia
        • Teva Investigational Site 144
      • Sydney, Australia
        • Teva Investigational Site 054
  • Canada
      • Montreal, Canada
        • Teva Investigational Site 098
      • North York, Canada
        • Teva Investigational Site 300
      • Ottawa, Canada
        • Teva Investigational Site 231
      • Ottawa, Canada
        • Teva Investigational Site 300
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Teva Investigational Site 057
    • Arizona
      • Phoenix, Arizona, United States
        • Teva Investigational Site 038
    • Arkansas
      • Fayetteville, Arkansas, United States
        • Teva Investigational Site 298
    • California
      • Los Angeles, California, United States
        • Teva Investigational Site 050
    • Colorado
      • Englewood, Colorado, United States
        • Teva Investigational Site 052
    • District of Columbia
      • Washington, D.C., District of Columbia, United States
        • Teva Investigational Site 333
    • Florida
      • Boca Raton, Florida, United States
        • Teva Investigational Site 196
      • Gainesville, Florida, United States
        • Teva Investigational Site 160
      • Miami, Florida, United States
        • Teva Investigational Site 014
    • Georgia
      • Atlanta, Georgia, United States
        • Teva Investigational Site 032
    • Indiana
      • Indianapolis, Indiana, United States
        • Teva Investigational Site 045
    • Iowa
      • Iowa City, Iowa, United States
        • Teva Investigational Site 024
    • Kansas
      • Kansas City, Kansas, United States
        • Teva Investigational Site 029
      • Wichita, Kansas, United States
        • Teva Investigational Site 083
    • Kentucky
      • Louisville, Kentucky, United States
        • Teva Investigational Site 087
    • Maryland
      • Baltimore, Maryland, United States
        • Teva Investigational Site 028
    • Massachusetts
      • Boston, Massachusetts, United States
        • Teva Investigational Site 040
    • Missouri
      • Saint Louis, Missouri, United States
        • Teva Investigational Site 027
    • Nevada
      • Las Vegas, Nevada, United States
        • Teva Investigational Site 194
    • New Jersey
      • Camden, New Jersey, United States
        • Teva Investigational Site 328
      • New Brunswick, New Jersey, United States
        • Teva Investigational Site 026
    • New York
      • Albany, New York, United States
        • Teva Investigational Site 037
      • New York, New York, United States
        • Teva Investigational Site 002
      • Patchogue, New York, United States
        • Teva Investigational Site 342
    • North Carolina
      • Durham, North Carolina, United States
        • Teva Investigational Site 119
    • Ohio
      • Cincinnati, Ohio, United States
        • Teva Investigational Site 089
      • Columbus, Ohio, United States
        • Teva Investigational Site 020
      • Toledo, Ohio, United States
        • Teva Investigational Site 093
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Teva Investigational Site 341
    • Tennessee
      • Nashville, Tennessee, United States
        • Teva Investigational Site 031
    • Texas
      • Houston, Texas, United States
        • Teva Investigational Site 007
      • Houston, Texas, United States
        • Teva Investigational Site 199
    • Utah
      • Salt Lake City, Utah, United States
        • Teva Investigational Site 100
    • Vermont
      • Burlington, Vermont, United States
        • Teva Investigational Site 137
    • Washington
      • Kirkland, Washington, United States
        • Teva Investigational Site 220
      • Seattle, Washington, United States
        • Teva Investigational Site 096
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Teva Investigational Site 104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • deutetrabenazine
Drug: Placebo
Placebo tablets are identical in appearance to SD-809 tablets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
Time Frame: Screening, Day 0, Weeks 9, 12
Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea
Screening, Day 0, Weeks 9, 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 weeks
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.
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
Time Frame: Baseline, 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.
Baseline, 12 weeks
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.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SD-809-C-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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