Phase 3 N=298 Randomized Triple-blind Treatment

Addressing Involuntary Movements in Tardive Dyskinesia

Tardive Dyskinesia

Bottom Line

View on ClinicalTrials.gov: NCT02291861 ↗

Enrolled (actual)

298

Serious AEs

5.5%

Results posted

Apr 2018

Primary outcome: Primary: Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM) — -1.4; -2.1; -3.2; -3.3 units on a scale — p=0.001

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: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)	-1.4; -2.1; -3.2; -3.3	0.001 sig
SECONDARY Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)	26; 28; 49; 44	0.059
SECONDARY Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12	-7.1; -5.8; -10.2; -10.7	0.207
SECONDARY Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)	31; 23; 45; 40	0.296
SECONDARY Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12	12; 13; 35; 33	0.007 sig
SECONDARY Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)	-11.6; -20.0; -31.9; -33.1	<0.001 sig
SECONDARY Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points	50; 62; 67; 71; 40; 47	—
SECONDARY Participants With Adverse Events During the Overall Treatment Period	34; 36; 32; 38; 4; 2	—

Summary

The purpose of this study is to determine whether fixed-doses of 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 must agree to an acceptable method of contraception throughout the study

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 or device within 30 days
Have acknowledged use of illicit drugs
Have a history of alcohol or substance abuse in the previous 12 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02291861). 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.