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MT-5199 in Tardive Dyskinesia
NCT03176771Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2017
- Primary completion
- Sep 2020
- Countries
- 1
- Sponsor
- Mitsubishi Tanabe Pharma
- Modality
- Orthosteric Ligands, Prodrugs/Conditional Activator Small Molecules
- Drugs
- valbenazine
- Conditions
- tardive dyskinesia (TD)
01
Overview
Phase 3, randomised, double-blind trial of valbenazine in tardive dyskinesia (TD) (5 arms), sponsored by Mitsubishi Tanabe Pharma. Primary endpoint: Abnormal Involuntary Movement Scale Total (Central Assessment) at 6 weeks. Started Jun 2017; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
MT-5199 40 mg
40 mg dose throughout study
MT-5199 80 mg
80 mg dose (after 1-week titration)
Placebo → MT-5199
Placebo for 6 weeks, then re-randomized to active treatment
MT-5199 40 mg Extension
40 mg in extension period
MT-5199 80 mg Extension
80 mg in extension period
03
Who it enrols
Patients with moderate to severe neuroleptic-induced tardive dyskinesia for at least 3 months, with underlying psychiatric diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder, or depressive disorders) for at least 3 months, on stable psychiatric medications, excluding those with unstable medical conditions, suicide/violence risk, cardiac arrhythmias, or pregnancy/breastfeeding
04
Endpoints
Primary
Abnormal Involuntary Movement Scale Total (Central Assessment)
Secondary
Percentage of Subjects With ≥50% Improvement From Baseline in AIMS Total (Central Assessment)
Abnormal Involuntary Movement Scale Total (Site Assessment)
Clinical Global Impression of Change - Tardive Dyskinesia
05
Results
Primary endpoints met
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