NCT07105111 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
| NCT ID | NCT07105111 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Neurocrine Biosciences |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-29 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-08-29 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Key Inclusion Criteria: * 18 years of age or older * Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder * Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening Key Exclusion Criteria: * Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD * Diagnosis of moderate or severe substance use disorder in the last 6 months * History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment
Contact & Investigator
Clinical Development Lead
STUDY DIRECTOR
Neurocrine Biosciences
Frequently Asked Questions
Who can join the NCT07105111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07105111 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07105111 currently recruiting?
Yes, NCT07105111 is actively recruiting participants. Contact the research team at medinfo@neurocrine.com for enrollment information.
Where is the NCT07105111 trial being conducted?
This trial is being conducted at Bryant, United States, Chino, United States, Fresno, United States, Long Beach, United States and 11 additional locations.
Who is sponsoring the NCT07105111 clinical trial?
NCT07105111 is sponsored by Neurocrine Biosciences. The principal investigator is Clinical Development Lead at Neurocrine Biosciences. The trial plans to enroll 100 participants.
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