A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Overview
- Phase
- Phase 2
- Intervention
- SD-809
- Conditions
- Tardive Dyskinesia
- Sponsor
- Auspex Pharmaceuticals, Inc.
- Enrollment
- 117
- Primary Endpoint
- Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Arms & Interventions
SD-809
SD-809 tablets taken twice daily for 12 weeks.
Intervention: SD-809
Sugar Pill
Placebo tablets taken twice daily for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis
Time Frame: Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12
AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement. A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point, treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. An unstructured covariance model was used.
Secondary Outcomes
- Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)(Week 12)
- Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)(Week 12)
- Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24)(Day 0 (Baseline), Week 12 with last observation carried forward)
- Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis(Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12)
- Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis(Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12)
- Participants With Adverse Events for the Overall Treatment Period(Day 1 to Week 12)
- Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12(Day 0 (Baseline), Week 12)