Brief Title
Reducing Involuntary Movements in Participants With Tardive Dyskinesia
Official Title
An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
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. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.
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 titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal
Secondary Outcome
Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating
Condition
Tardive Dyskinesia
Intervention
SD-809
Study Arms / Comparison Groups
Part A: SD-809
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
343
Start Date
October 20, 2014
Completion Date
December 14, 2020
Primary Completion Date
December 6, 2019
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Teva Medical Expert, M.D., ,
Location Countries
Czechia
Location Countries
Czechia
Administrative Informations
NCT ID
NCT02198794
Organization ID
SD-809-C-20
Secondary IDs
2014-001891-73
Responsible Party
Sponsor
Study Sponsor
Auspex Pharmaceuticals, Inc.
Study Sponsor
Teva Medical Expert, M.D., Study Director, Teva Branded Pharmaceutical Products R&D, Inc.
Verification Date
March 2022