First Time Use of SD-809 in Huntington Disease

NCT01795859 | Completed Phase 3 Results DMC

• 1 other identifier: SD-809-C-15
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 43

Brief 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.

Conditions

Chorea

Keywords

Huntington disease; Chorea; Tetrabenazine

Outcome Measures

Primary Outcomes (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

  Screening, Day 0, Weeks 9, 12

Secondary Outcomes (4)

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

  12 weeks

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

  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

  Baseline, 12 weeks

• Change in Berg Balance Test (BBT)

  Baseline, 12 weeks

Study Arms (2)

SD-809 ER Tablets

EXPERIMENTAL

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; Drug: Placebo

SD-809 Tablets

EXPERIMENTAL

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; Drug: Placebo

Interventions

SD-809 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).

Also known as: deutetrabenazine

SD-809 ER Tablets; SD-809 Tablets

Placebo DRUG

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

SD-809 ER Tablets; SD-809 Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (43)

Teva Investigational Site 057

Birmingham, Alabama, United States

Location

Teva Investigational Site 038

Phoenix, Arizona, United States

Location

Teva Investigational Site 298

Fayetteville, Arkansas, United States

Location

Teva Investigational Site 050

Los Angeles, California, United States

Location

Teva Investigational Site 052

Englewood, Colorado, United States

Location

Teva Investigational Site 333

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

Location

Teva Investigational Site 196

Boca Raton, Florida, United States

Location

Teva Investigational Site 160

Gainesville, Florida, United States

Location

Teva Investigational Site 014

Miami, Florida, United States

Location

Teva Investigational Site 032

Atlanta, Georgia, United States

Location

Teva Investigational Site 045

Indianapolis, Indiana, United States

Location

Teva Investigational Site 024

Iowa City, Iowa, United States

Location

Teva Investigational Site 029

Kansas City, Kansas, United States

Location

Teva Investigational Site 083

Wichita, Kansas, United States

Location

Teva Investigational Site 087

Louisville, Kentucky, United States

Location

Teva Investigational Site 028

Baltimore, Maryland, United States

Location

Teva Investigational Site 040

Boston, Massachusetts, United States

Location

Teva Investigational Site 027

St Louis, Missouri, United States

Location

Teva Investigational Site 194

Las Vegas, Nevada, United States

Location

Teva Investigational Site 328

Camden, New Jersey, United States

Location

Teva Investigational Site 026

New Brunswick, New Jersey, United States

Location

Teva Investigational Site 037

Albany, New York, United States

Location

Teva Investigational Site 002

New York, New York, United States

Location

Teva Investigational Site 342

Patchogue, New York, United States

Location

Teva Investigational Site 119

Durham, North Carolina, United States

Location

Teva Investigational Site 089

Cincinnati, Ohio, United States

Location

Teva Investigational Site 020

Columbus, Ohio, United States

Location

Teva Investigational Site 093

Toledo, Ohio, United States

Location

Teva Investigational Site 341

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 031

Nashville, Tennessee, United States

Location

Teva Investigational Site 007

Houston, Texas, United States

Location

Teva Investigational Site 199

Houston, Texas, United States

Location

Teva Investigational Site 100

Salt Lake City, Utah, United States

Location

Teva Investigational Site 137

Burlington, Vermont, United States

Location

Teva Investigational Site 220

Kirkland, Washington, United States

Location

Teva Investigational Site 096

Seattle, Washington, United States

Location

Teva Investigational Site 104

Milwaukee, Wisconsin, United States

Location

Teva Investigational Site 144

Kew Vic, Australia

Location

Teva Investigational Site 054

Sydney, Australia

Location

Teva Investigational Site 098

Montreal, Canada

Location

Teva Investigational Site 300

North York, Canada

Location

Teva Investigational Site 231

Ottawa, Canada

Location

Teva Investigational Site 300

Ottawa, Canada

Location

Related Publications (5)

• 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.

  PMID: 39825184 DERIVED

• 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.

  PMID: 38557959 DERIVED

• 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.

  PMID: 29480210 DERIVED

• 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.

  PMID: 28265459 DERIVED

• 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.

  PMID: 27380342 DERIVED

MeSH Terms

Conditions

Chorea; Huntington Disease

Interventions

deutetrabenazine

Condition Hierarchy (Ancestors)

Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Dementia; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

ustevatrials@tevapharm.com

215-591-3000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 21, 2013
• Study Start: August 5, 2013
• Primary Completion: December 5, 2014
• Study Completion: December 5, 2014
• Last Updated: September 20, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-08

Locations

AU (2); US (37); CA (4)