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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) | 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 |
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Inclusion Criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 057 | Birmingham | Alabama | United States | |||
| Teva Investigational Site 038 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39825184 | Derived | 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. | |
| 38557959 |
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A total of 90 subjects were randomized 1:1 to receive either SD-809 or placebo. All subjects were assessed for capacity to provide informed consent and written informed consent was obtained appropriately
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| ID | Title | Description |
|---|---|---|
| FG000 | SD-809 Tablets | 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). |
| FG001 | SD-809 Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Placebo tablets are identical in appearance to SD-809 tablets. |
|
| 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. |
| 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 | 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) | 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 |
| Phoenix |
| Arizona |
| United States |
| Teva Investigational Site 298 | Fayetteville | Arkansas | United States |
| Teva Investigational Site 050 | Los Angeles | California | United States |
| Teva Investigational Site 052 | Englewood | Colorado | United States |
| Teva Investigational Site 333 | Washington D.C. | District of Columbia | United States |
| Teva Investigational Site 196 | Boca Raton | Florida | United States |
| Teva Investigational Site 160 | Gainesville | Florida | United States |
| Teva Investigational Site 014 | Miami | Florida | United States |
| Teva Investigational Site 032 | Atlanta | Georgia | United States |
| Teva Investigational Site 045 | Indianapolis | Indiana | United States |
| Teva Investigational Site 024 | Iowa City | Iowa | United States |
| Teva Investigational Site 029 | Kansas City | Kansas | United States |
| Teva Investigational Site 083 | Wichita | Kansas | United States |
| Teva Investigational Site 087 | Louisville | Kentucky | United States |
| Teva Investigational Site 028 | Baltimore | Maryland | United States |
| Teva Investigational Site 040 | Boston | Massachusetts | United States |
| Teva Investigational Site 027 | St Louis | Missouri | United States |
| Teva Investigational Site 194 | Las Vegas | Nevada | United States |
| Teva Investigational Site 328 | Camden | New Jersey | United States |
| Teva Investigational Site 026 | New Brunswick | New Jersey | United States |
| Teva Investigational Site 037 | Albany | New York | United States |
| Teva Investigational Site 002 | New York | New York | United States |
| Teva Investigational Site 342 | Patchogue | New York | United States |
| Teva Investigational Site 119 | Durham | North Carolina | United States |
| Teva Investigational Site 089 | Cincinnati | Ohio | United States |
| Teva Investigational Site 020 | Columbus | Ohio | United States |
| Teva Investigational Site 093 | Toledo | Ohio | United States |
| Teva Investigational Site 341 | Tulsa | Oklahoma | United States |
| Teva Investigational Site 031 | Nashville | Tennessee | United States |
| Teva Investigational Site 007 | Houston | Texas | United States |
| Teva Investigational Site 199 | Houston | Texas | United States |
| Teva Investigational Site 100 | Salt Lake City | Utah | United States |
| Teva Investigational Site 137 | Burlington | Vermont | United States |
| Teva Investigational Site 220 | Kirkland | Washington | United States |
| Teva Investigational Site 096 | Seattle | Washington | United States |
| Teva Investigational Site 104 | Milwaukee | Wisconsin | United States |
| Teva Investigational Site 144 | Kew Vic | Australia |
| Teva Investigational Site 054 | Sydney | Australia |
| Teva Investigational Site 098 | Montreal | Canada |
| Teva Investigational Site 300 | North York | Canada |
| Teva Investigational Site 231 | Ottawa | Canada |
| Teva Investigational Site 300 | Ottawa | Canada |
| 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. |
| 29480210 | 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. |
| 28265459 | 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. |
| 27380342 | 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. |
Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SD-809 Tablets | 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). |
| BG001 | SD-809 Placebo | Placebo: Placebo tablets are identical in appearance to SD-809 tablets. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects who missed both Week 9 or Week 12 scores, the last available assessment was used | Posted | Least Squares Mean | Standard Deviation | Units on a scale | Screening, Day 0, Weeks 9, 12 |
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| Secondary | 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 | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post baseline assessment. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | 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. | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post-baseline assessment. | Posted | Count of Participants | Participants | 12 weeks |
|
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| Secondary | 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. | The modified intent to treat (mITT) population will include all subjects in the ITT population who were randomized to treatment and received study drug. For subjects with missing value at Week 12, the last available assessment was used | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
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| Secondary | 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. | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects with missing value at Week 12, the last available assessment was used | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 1 | 45 | 21 | 45 | ||
| EG001 | SD-809 | SD-809 | 1 | 45 | 18 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis chronic | Hepatobiliary disorders | Systematic Assessment |
| ||
| Agitated depression | Psychiatric disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Irritability | General disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products R&D, Inc. | 215-591-3000 | ustevatrials@tevapharm.com |
| ID | Term |
|---|---|
| D002819 | Chorea |
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D003704 | Dementia |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000609690 | deutetrabenazine |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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