Reducing Involuntary Movements in Tardive Dyskinesia



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:6/3/2016
Start Date:October 2014
End Date:August 2018
Contact:Teva U.S. Medical Information
Phone:1-800-896-5855

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An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe
tardive dyskinesia.


Inclusion Criteria:

- 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

- Subject has successfully completed a controlled study of SD-809 for treatment of
moderate to severe tardive dyskinesia

- 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:

- 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
We found this trial at
55
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Anaheim, California
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Albuquerque, New Mexico 87102
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Charleston, South Carolina
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Garfield Heights, Ohio 44125
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Lincoln, Nebraska 68510
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