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 — DRUG
    Valbenazine 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

Start date
Aug 29, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Valbenazine
    Valbenazine 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

Locations (22)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteBryantArkansas72022-
Neurocrine Clinical SiteChinoCalifornia91710-
Neurocrine Clinical SiteFountain ValleyCalifornia92708-
Neurocrine Clinical SiteFresnoCalifornia93720-
Neurocrine Clinical SiteLong BeachCalifornia90807-
Neurocrine Clinical SiteOrangeCalifornia92866-
Neurocrine Clinical SiteRedlandsCalifornia92373-
Neurocrine Clinical SiteSan DiegoCalifornia92123-
Neurocrine Clinical SiteBonita SpringsFlorida34134-
Neurocrine Clinical SiteHialeahFlorida33012-
Neurocrine Clinical SiteMiamiFlorida33144-
Neurocrine Clinical SiteMiamiFlorida33176-
Neurocrine Clinical SiteOrange CityFlorida32763-
Neurocrine Clinical SitePort CharlotteFlorida33980-
Neurocrine Clinical SiteTampaFlorida33629-
Neurocrine Clinical SiteAugustaGeorgia30912-
Neurocrine Clinical SiteMariettaGeorgia30060-
Neurocrine Clinical SiteNapervilleIllinois60563-
Neurocrine Clinical SiteOmahaNebraska68124-
Neurocrine Clinical SiteIndependenceOhio44131-
Neurocrine Clinical SiteAustinTexas78754-
Neurocrine Clinical SiteRichmondVirginia23226-

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