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ChoreaPhase 3First-HDNCT01795859

First Time Use of SD-809 in Huntington Disease

A Phase 3 study testing SD-809 in people with Chorea, run by Teva Branded Pharmaceutical Products R&D, Inc. at 43 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chorea
What is being tested?
SD-809
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
43 sitesin 3 countries
Study dates
5 Aug 2013to 5 Dec 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

43 sites in 3 countries.

43 sites in 3 countries

United States37 sites

  • Teva Investigational Site 037

    Albany, New York

  • Teva Investigational Site 032

    Atlanta, Georgia

  • Teva Investigational Site 028

    Baltimore, Maryland

  • Teva Investigational Site 057

    Birmingham, Alabama

  • Teva Investigational Site 196

    Boca Raton, Florida

  • Teva Investigational Site 040

    Boston, Massachusetts

  • Teva Investigational Site 137

    Burlington, Vermont

  • Teva Investigational Site 328

    Camden, New Jersey

  • Teva Investigational Site 089

    Cincinnati, Ohio

  • Teva Investigational Site 020

    Columbus, Ohio

  • Teva Investigational Site 119

    Durham, North Carolina

  • Teva Investigational Site 052

    Englewood, Colorado

  • Teva Investigational Site 298

    Fayetteville, Arkansas

  • Teva Investigational Site 160

    Gainesville, Florida

  • Teva Investigational Site 007

    Houston, Texas

  • Teva Investigational Site 199

    Houston, Texas

  • Teva Investigational Site 045

    Indianapolis, Indiana

  • Teva Investigational Site 024

    Iowa City, Iowa

  • Teva Investigational Site 029

    Kansas City, Kansas

  • Teva Investigational Site 220

    Kirkland, Washington

  • Teva Investigational Site 194

    Las Vegas, Nevada

  • Teva Investigational Site 050

    Los Angeles, California

  • Teva Investigational Site 087

    Louisville, Kentucky

  • Teva Investigational Site 014

    Miami, Florida

  • Teva Investigational Site 104

    Milwaukee, Wisconsin

  • Teva Investigational Site 031

    Nashville, Tennessee

  • Teva Investigational Site 026

    New Brunswick, New Jersey

  • Teva Investigational Site 002

    New York, New York

  • Teva Investigational Site 342

    Patchogue, New York

  • Teva Investigational Site 038

    Phoenix, Arizona

  • Teva Investigational Site 100

    Salt Lake City, Utah

  • Teva Investigational Site 096

    Seattle, Washington

  • Teva Investigational Site 027

    St Louis, Missouri

  • Teva Investigational Site 093

    Toledo, Ohio

  • Teva Investigational Site 341

    Tulsa, Oklahoma

  • Teva Investigational Site 333

    Washington D.C., District of Columbia

  • Teva Investigational Site 083

    Wichita, Kansas

Other trials in United States

Canada4 sites

  • Teva Investigational Site 098

    Montreal

  • Teva Investigational Site 300

    North York

  • Teva Investigational Site 231

    Ottawa

  • Teva Investigational Site 300

    Ottawa

Other trials in Canada

Australia2 sites

  • Teva Investigational Site 144

    Kew Vic

  • Teva Investigational Site 054

    Sydney

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Conditions
Chorea
Being tested
SD-809, Placebo
Keywords
Huntington disease, Chorea, Tetrabenazine
Medical subject headings
Chorea, Huntington Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SD-809Drug

    Also called deutetrabenazine

    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).

  • PlaceboDrug

    Placebo tablets are identical in appearance to SD-809 tablets.

Study groups in NCT01795859
Study groupRoleWhat they receive
SD-809 ER TabletsExperimentalSD-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.
Receives: Drug: SD-809; Drug: Placebo
SD-809 TabletsExperimentalSD-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.
Receives: Drug: SD-809; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12

    Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea

    Measured: Screening, Day 0, Weeks 9, 12

Secondary outcomes (4)

  1. Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)

    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

    Measured: 12 weeks

  2. Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)

    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.

    Measured: 12 weeks

  3. Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12

    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.

    Measured: Baseline, 12 weeks

  4. Change in Berg Balance Test (BBT)

    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.

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2013 (estimated)
  2. Study start5 Aug 2013
  3. Primary completion5 Dec 2014
  4. Study completion5 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01795859
Sponsor's protocol ID
SD-809-C-15
Acronym
First-HD
Status last verified
Aug 2017
First submitted
20 Feb 2013
Last updated
20 Sep 2017
Data monitoring committee
Yes

Publications

  • Frank S, Testa CM, Goldstein J, Kayson E, Leavitt BR, Oakes D, O'Neill C, Whaley J, Gross N, Chaijale N, Barash S, Gordon MF; Huntington Study Group/ARC-HD Investigators and Coordinators. Safety and Efficacy of Deutetrabenazine at High versus Lower Daily Dosages in the ARC-HD Study to Treat Chorea in Huntington Disease. CNS Drugs. 2025 Feb;39(2):185-195. doi: 10.1007/s40263-024-01139-3. Epub 2025 Jan 18.

    PubMed 39825184

  • Frank S, Anderson KE, Fernandez HH, Hauser RA, Claassen DO, Stamler D, Factor SA, Jimenez-Shahed J, Barkay H, Wilhelm A, Alexander JK, Chaijale N, Barash S, Savola JM, Gordon MF, Chen M. Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease. Neurol Ther. 2024 Jun;13(3):655-675. doi: 10.1007/s40120-024-00600-1. Epub 2024 Apr 1.

    PubMed 38557959

  • Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: February 2018. J Huntingtons Dis. 2018;7(1):89-98. doi: 10.3233/JHD-189001.

    PubMed 29480210

  • Claassen DO, Carroll B, De Boer LM, Wu E, Ayyagari R, Gandhi S, Stamler D. Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease. J Clin Mov Disord. 2017 Mar 1;4:3. doi: 10.1186/s40734-017-0051-5. eCollection 2017.

    PubMed 28265459

  • Huntington Study Group; Frank S, Testa CM, Stamler D, Kayson E, Davis C, Edmondson MC, Kinel S, Leavitt B, Oakes D, O'Neill C, Vaughan C, Goldstein J, Herzog M, Snively V, Whaley J, Wong C, Suter G, Jankovic J, Jimenez-Shahed J, Hunter C, Claassen DO, Roman OC, Sung V, Smith J, Janicki S, Clouse R, Saint-Hilaire M, Hohler A, Turpin D, James RC, Rodriguez R, Rizer K, Anderson KE, Heller H, Carlson A, Criswell S, Racette BA, Revilla FJ, Nucifora F Jr, Margolis RL, Ong M, Mendis T, Mendis N, Singer C, Quesada M, Paulsen JS, Brashers-Krug T, Miller A, Kerr J, Dubinsky RM, Gray C, Factor SA, Sperin E, Molho E, Eglow M, Evans S, Kumar R, Reeves C, Samii A, Chouinard S, Beland M, Scott BL, Hickey PT, Esmail S, Fung WL, Gibbons C, Qi L, Colcher A, Hackmyer C, McGarry A, Klos K, Gudesblatt M, Fafard L, Graffitti L, Schneider DP, Dhall R, Wojcieszek JM, LaFaver K, Duker A, Neefus E, Wilson-Perez H, Shprecher D, Wall P, Blindauer KA, Wheeler L, Boyd JT, Houston E, Farbman ES, Agarwal P, Eberly SW, Watts A, Tariot PN, Feigin A, Evans S, Beck C, Orme C, Edicola J, Christopher E. Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):40-50. doi: 10.1001/jama.2016.8655.

    PubMed 27380342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SD-809 in people with Chorea, run by Teva Branded Pharmaceutical Products R&D, Inc. at 43 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01795859, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.

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