Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
117 participants
INTERVENTIONAL
2014-06-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SD-809
SD-809 tablets taken twice daily for 12 weeks.
SD-809
SD-809 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period.
Sugar Pill
Placebo tablets taken twice daily for 12 weeks.
Placebo
Placebo tablets taken twice daily for 12 weeks.
Interventions
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SD-809
SD-809 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period.
Placebo
Placebo tablets taken twice daily for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Auspex Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, M.D.
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Tuscaloosa, Alabama, United States
Anaheim, California, United States
Glendale, California, United States
Oceanside, California, United States
Orange, California, United States
San Bernardino, California, United States
San Diego, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Stamford, Connecticut, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Lake City, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Port Charlotte, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Prague, , Czechia
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Torun, , Poland
Domaša, , Slovakia
Rožňava, , Slovakia
Countries
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References
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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.
Other Identifiers
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SD-809-C-18
Identifier Type: -
Identifier Source: org_study_id