Status:
COMPLETED
Reducing Involuntary Movements in Participants With Tardive Dyskinesia
Lead Sponsor:
Auspex Pharmaceuticals, Inc.
Conditions:
Tardive Dyskinesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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....
Detailed Description
Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titrat...
Eligibility Criteria
Inclusion
- 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
- Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia
- Participants 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 participants must not be pregnant and agree to an acceptable method of contraception
Exclusion
- 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 (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) 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
Key Trial Info
Start Date :
October 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT02198794
Start Date
October 20 2014
End Date
December 14 2020
Last Update
April 1 2022
Active Locations (82)
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1
Teva Investigational Site 145
Tuscaloosa, Alabama, United States, 35404
2
Teva Investigational Site 107
Anaheim, California, United States, 92804
3
Teva Investigational Site 108
Anaheim, California, United States, 92805
4
Teva Investigational Site 123
Glendale, California, United States, 91206