Aim to Reduce Movements in Tardive Dyskinesia
ARM-TD
A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
1 other identifier
interventional
117
4 countries
41
Brief Summary
The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2014
Shorter than P25 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 18, 2014
CompletedFirst Posted
Study publicly available on registry
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
March 20, 2018
CompletedNovember 9, 2021
November 1, 2021
11 months
July 18, 2014
January 3, 2018
November 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis
AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement. A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point, treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. An unstructured covariance model was used.
Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12
Secondary Outcomes (7)
Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)
Week 12
Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)
Week 12
Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24)
Day 0 (Baseline), Week 12 with last observation carried forward
Participants With Adverse Events for the Overall Treatment Period
Day 1 to Week 12
Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis
Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12
- +2 more secondary outcomes
Study Arms (2)
SD-809
EXPERIMENTALSD-809 tablets taken twice daily for 12 weeks.
Sugar Pill
PLACEBO COMPARATORPlacebo tablets taken twice daily for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- History of using a dopamine receptor antagonist for at least 3 months
- Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
- Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
- Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
- History of being compliant with prescribed medications
- Able to swallow study drug whole
- Be in good general health and is expected to attend all study visits and complete study assessments
- Female subjects must not be pregnant and agree to an acceptable method of contraception
You may not qualify if:
- Currently receiving medication for the treatment of tardive dyskinesia
- Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
- Have a serious untreated or undertreated psychiatric illness
- Have recent history or presence of violent behavior
- Have unstable or serious medical illness
- Have evidence of hepatic impairment
- Have evidence of renal impairment
- Have known allergy to any component of SD-809 or tetrabenazine
- Has participated in an investigational drug or device trial and received study drug within 30 days
- Have acknowledged use of illicit drugs
- Have a history of alcohol or substance abuse in the previous 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Tuscaloosa, Alabama, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
Orange, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Stamford, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Boca Raton, Florida, United States
Unknown Facility
Gainesville, Florida, United States
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Lake City, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
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Port Charlotte, Florida, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Minneapolis, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Fort Worth, Texas, United States
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Salt Lake City, Utah, United States
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Prague, Czechia
Unknown Facility
Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
Unknown Facility
Torun, Poland
Unknown Facility
Domaša, Slovakia
Unknown Facility
Rožňava, Slovakia
Related Publications (1)
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: 38557959DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc
Study Officials
- STUDY DIRECTOR
Teva Medical Expert, M.D.
Teva Branded Pharmaceutical Products R&D, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2014
First Posted
July 21, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
November 9, 2021
Results First Posted
March 20, 2018
Record last verified: 2021-11