Phase 3
N=117
Aim to Reduce Movements in Tardive Dyskinesia
Tardive Dyskinesia
Bottom Line
View on ClinicalTrials.gov: NCT02195700 ↗Enrolled (actual)
117
Serious AEs
6.8%
Results posted
Mar 2018
Primary outcome: Primary: Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis — -3.0; -1.6 units on a scale — p=0.0188
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SD-809 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Auspex Pharmaceuticals, Inc.
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis |
-3.0; -1.6 | 0.0188 sig |
| SECONDARY Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) |
48.2; 40.4 | 0.4001 |
| SECONDARY Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC) |
42.9; 29.8 | — |
| SECONDARY Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24) |
-11.1; -8.3 | — |
| SECONDARY Participants With Adverse Events for the Overall Treatment Period |
41; 36; 3; 5; 3; 3 | — |
| SECONDARY Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis |
-26.7; -15.5 | — |
| SECONDARY Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12 |
69.6; 42.1; 50.0; 29.8; 46.4; 24.6 | — |
| SECONDARY Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis |
-4.9; -3.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02195700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.