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First Time Use of SD-809 in Huntington Disease

NCT ID: NCT01795859

Last Updated: 2017-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-05

Study Completion Date

2014-12-05

Brief Summary

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

Detailed Description

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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

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Chorea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

SD-809

Intervention Type DRUG

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).

Placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

SD-809

Intervention Type DRUG

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).

Placebo

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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deutetrabenazine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Teva Investigational Site 057

Birmingham, Alabama, United States

Site Status

Teva Investigational Site 038

Phoenix, Arizona, United States

Site Status

Teva Investigational Site 298

Fayetteville, Arkansas, United States

Site Status

Teva Investigational Site 050

Los Angeles, California, United States

Site Status

Teva Investigational Site 052

Englewood, Colorado, United States

Site Status

Teva Investigational Site 333

Washington D.C., District of Columbia, United States

Site Status

Teva Investigational Site 196

Boca Raton, Florida, United States

Site Status

Teva Investigational Site 160

Gainesville, Florida, United States

Site Status

Teva Investigational Site 014

Miami, Florida, United States

Site Status

Teva Investigational Site 032

Atlanta, Georgia, United States

Site Status

Teva Investigational Site 045

Indianapolis, Indiana, United States

Site Status

Teva Investigational Site 024

Iowa City, Iowa, United States

Site Status

Teva Investigational Site 029

Kansas City, Kansas, United States

Site Status

Teva Investigational Site 083

Wichita, Kansas, United States

Site Status

Teva Investigational Site 087

Louisville, Kentucky, United States

Site Status

Teva Investigational Site 028

Baltimore, Maryland, United States

Site Status

Teva Investigational Site 040

Boston, Massachusetts, United States

Site Status

Teva Investigational Site 027

St Louis, Missouri, United States

Site Status

Teva Investigational Site 194

Las Vegas, Nevada, United States

Site Status

Teva Investigational Site 328

Camden, New Jersey, United States

Site Status

Teva Investigational Site 026

New Brunswick, New Jersey, United States

Site Status

Teva Investigational Site 037

Albany, New York, United States

Site Status

Teva Investigational Site 002

New York, New York, United States

Site Status

Teva Investigational Site 342

Patchogue, New York, United States

Site Status

Teva Investigational Site 119

Durham, North Carolina, United States

Site Status

Teva Investigational Site 089

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 020

Columbus, Ohio, United States

Site Status

Teva Investigational Site 093

Toledo, Ohio, United States

Site Status

Teva Investigational Site 341

Tulsa, Oklahoma, United States

Site Status

Teva Investigational Site 031

Nashville, Tennessee, United States

Site Status

Teva Investigational Site 007

Houston, Texas, United States

Site Status

Teva Investigational Site 199

Houston, Texas, United States

Site Status

Teva Investigational Site 100

Salt Lake City, Utah, United States

Site Status

Teva Investigational Site 137

Burlington, Vermont, United States

Site Status

Teva Investigational Site 220

Kirkland, Washington, United States

Site Status

Teva Investigational Site 096

Seattle, Washington, United States

Site Status

Teva Investigational Site 104

Milwaukee, Wisconsin, United States

Site Status

Teva Investigational Site 144

Kew Vic, , Australia

Site Status

Teva Investigational Site 054

Sydney, , Australia

Site Status

Teva Investigational Site 098

Montreal, , Canada

Site Status

Teva Investigational Site 300

North York, , Canada

Site Status

Teva Investigational Site 231

Ottawa, , Canada

Site Status

Teva Investigational Site 300

Ottawa, , Canada

Site Status

Countries

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United States Australia Canada

References

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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.

Reference Type DERIVED
PMID: 39825184 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38557959 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29480210 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28265459 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27380342 (View on PubMed)

Other Identifiers

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SD-809-C-15

Identifier Type: -

Identifier Source: org_study_id