Valbenazine for Tardive Dyskinesia

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Neurocrine Biosciences

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial will test how well valbenazine improves quality of life and functioning in people with tardive dyskinesia over several months. Valbenazine is approved to treat tardive dyskinesia (TD) in adults.

Research Team

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Eligibility Criteria

This trial is for adults with tardive dyskinesia, a movement disorder often related to long-term use of certain psychiatric medications. Participants must be stable outpatients with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder and on a steady medication regimen. Those with more prominent involuntary movements not due to TD or significant unstable medical conditions are excluded.

Inclusion Criteria

I have been diagnosed with TD due to antipsychotic medication.

I have been diagnosed with TD due to neuroleptics for over three months.

I have been on a stable dose of medication for my mental health condition for the last 30 days.

Exclusion Criteria

I have involuntary movements more noticeable than my tardive dyskinesia.

Do you have a diagnosis of moderate or severe substance use disorder within the last 6 months?

Are you a significant risk for suicidal or violent behavior?

Treatment Details

Interventions

• Valbenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor)

Trial Overview The study tests the effectiveness of valbenazine over a period of up to 24 weeks. It focuses on how well valbenazine improves the quality of life, functioning, and perceived treatment effect in patients as reported by both themselves and their clinicians.

Participant Groups

Group I: Valbenazine Experimental Treatment 1 Intervention

Valbenazine administered once daily for 24 weeks.

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD