Phase 3
N=337
Reducing Involuntary Movements in Participants With Tardive Dyskinesia
Tardive Dyskinesia
Bottom Line
View on ClinicalTrials.gov: NCT02198794 ↗Enrolled (actual)
337
Serious AEs
17.5%
Results posted
Mar 2021
Primary outcome: Primary: 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 — 269; 23; 68; 5 Participants
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
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
269; 23; 68; 5; 57; 3 | — |
| PRIMARY Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating |
5.7; 5.0; 0.6; 0 | 0.121 |
| SECONDARY Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating |
-6.6 | — |
| SECONDARY Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating |
-6.3 | — |
| SECONDARY Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating |
-57.0 | — |
| SECONDARY Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating |
-54.9 | — |
| SECONDARY Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating |
67 | — |
| SECONDARY Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating |
42 | — |
| SECONDARY Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating |
-1.3; -1.3; -1.3 | — |
| SECONDARY Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC) |
73 | — |
| SECONDARY Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC) |
63 | — |
| SECONDARY Part A: Change From Baseline in Modified CDQ-24 Score at Week 158 |
-6.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02198794). 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.