A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Part of paid clinical trials in Bryant, Arkansas.
- Sponsor
- Neurocrine Biosciences
- Study ID
- NCT07105111
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Valbenazine — DRUGValbenazine capsules for oral administration.
Study Details
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
Key Dates
- First listed
- Aug 5, 2025
- Start date
- Aug 29, 2025
- Status verified
- Sep 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ValbenazineValbenazine administered once daily for 24 weeks.
Primary Outcome Measure
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24 [ Time Frame: Baseline, Week 24 ]
Central Contacts
- Neurocrine Medical Information Call Center1-877-641-3461
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Neurocrine Clinical Site | Bryant | Arkansas | 72022 | - |
| Neurocrine Clinical Site | Chino | California | 91710 | - |
| Neurocrine Clinical Site | Fresno | California | 93701 | - |
| Neurocrine Clinical Site | Long Beach | California | 90807 | - |
| Neurocrine Clinical Site | Orange | California | 92866 | - |
| Neurocrine Clinical Site | Redlands | California | 92373 | - |
| Neurocrine Clinical Site | San Diego | California | 92123 | - |
| Neurocrine Clinical Site | Bonita Springs | Florida | 34134 | - |
| Neurocrine Clinical Site | Hialeah | Florida | 33012 | - |
| Neurocrine Clinical Site | Miami | Florida | 33176 | - |
| Neurocrine Clinical Site | Orange City | Florida | 32763 | - |
| Neurocrine Clinical Site | Port Charlotte | Florida | 33980 | - |
| Neurocrine Clinical Site | Tampa | Florida | 33629 | - |
| Neurocrine Clinical Site | Augusta | Georgia | 30912 | - |
| Neurocrine Clinical Site | Naperville | Illinois | 60563 | - |
| Neurocrine Clinical Site | Omaha | Nebraska | 68124 | - |
| Neurocrine Clinical Site | Independence | Ohio | 44131 | - |
| Neurocrine Clinical Site | Austin | Texas | 78754 | - |
| Neurocrine Clinical Site | Richmond | Virginia | 23226 | - |
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