Aim to Reduce Movements in Tardive Dyskinesia



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:June 2014
End Date:May 2015

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A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

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.


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

- 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
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33
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Stamford, CT
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