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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

StatusRecruiting
PhasePhase 4
Started2025-08-29
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 16 months later Jan 2027 → Jun 2028
See other at-risk trials from Neurocrine Biosciences

Amendment history

2026-09-19
Enrollment increased: 50 → 100 participants
Trial sites reduced: 22 → 19 locations
Primary completion pushed: 2027-01 → 2028-06
Completion pushed: 2027-01 → 2028-06
2026-06-15
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 22 sites
2026-06-10
Study Status, Contacts/Locations v5
Study sites21→22
2026-05-06
Study Status, Contacts/Locations v4
Study sites19→21
2026-04-13
Study Status, Contacts/Locations, IPDSharing v3
Primary completion date2027-04→2027-01
Completion date2027-04→2027-01
Study sites8→19
Show 2 earlier versions
2025-10-20
Study Status, Contacts/Locations v2
Study sites5→8
2025-09-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-08-29
Study sites0→5
2025-07-29
Original filing
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.
Trial Details
NCT Number NCT07105111
Lead Sponsor Neurocrine Biosciences
Conditions Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia
Enrollment 100 participants
Start Date 2025-08-29
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-18