Brief Title
Aim to Reduce Movements in Tardive Dyskinesia
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Brief Summary
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis
Secondary Outcome
Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)
Condition
Tardive Dyskinesia
Intervention
SD-809
Study Arms / Comparison Groups
SD-809
Description: SD-809 tablets taken twice daily for 12 weeks.
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
117
Start Date
June 2014
Completion Date
May 2015
Primary Completion Date
May 2015
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 - 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Teva Medical Expert, M.D., ,
Location Countries
Czechia
Location Countries
Czechia
Administrative Informations
NCT ID
NCT02195700
Organization ID
SD-809-C-18
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
November 2021