Reducing Involuntary Movements in Participants With Tardive Dyskinesia (RIM-TD)
Tardive Dyskinesia
About this trial
This is an interventional treatment trial for Tardive Dyskinesia focused on measuring Dyskinesias, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Signs and Symptoms
Eligibility Criteria
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
- 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 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 (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
Sites / Locations
- Teva Investigational Site 145
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Active Comparator
Experimental
Part A: SD-809
Part B: Placebo
Part B: SD-809
Part C: SD-809
Participants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158.
Participants will receive placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter will receive SD-809 (stable dose) for 12 weeks.
Participants will receive SD-809 (stable dose) for 1 week in randomized withdrawal period and will continue to receive the same dose of SD-809 for an additional 12 weeks.
EU participants who complete Part B and willing to continue in the study will continue treatment with SD-809 for 52 weeks at the dose administered during the 12-week open-label period of Part B.