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 |
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.
(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
We found this trial at
33
sites
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