Valbenazine for Tardive Dyskinesia

Recruiting at 7 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Neurocrine Biosciences

Must be taking: VMAT2 inhibitors

Disqualifiers: Parkinsonism, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests valbenazine, a medication, to evaluate its effectiveness for people with tardive dyskinesia (TD), a condition causing uncontrollable movements. The focus is on how the drug affects symptoms as reported by both doctors and patients. The trial includes individuals who have had TD for at least three months and are managing conditions like schizophrenia, bipolar disorder, or major depressive disorder. Participants should not have more serious movement disorders or recent substance abuse problems. This trial may be suitable for those seeking new treatment options. As a Phase 4 trial, valbenazine has already received FDA approval and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be receiving or have stopped a VMAT2 inhibitor, which suggests some flexibility. It's best to discuss your specific medications with the trial team.

What is the safety track record for this treatment?

Research has shown that valbenazine is generally safe for people with tardive dyskinesia (TD). Studies have found it to be well-tolerated, even with long-term use. Some research indicates that patients, including older adults, can safely use valbenazine for up to 48 weeks, experiencing few serious side effects during that time. Overall, valbenazine appears to be a safe option for managing TD symptoms. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Valbenazine is unique because it specifically targets tardive dyskinesia by inhibiting VMAT2 (vesicular monoamine transporter 2), a protein involved in regulating dopamine levels in the brain. Unlike other treatments for tardive dyskinesia, which might involve off-label use of antipsychotics or benzodiazepines, Valbenazine is designed to directly address the root cause of the involuntary movements associated with the condition. Researchers are excited about Valbenazine because its precise mechanism of action offers the potential for effective symptom control with once-daily dosing, which can simplify treatment regimens and improve patient adherence.

What is the effectiveness track record for valbenazine in treating tardive dyskinesia?

Research has shown that valbenazine helps treat tardive dyskinesia (TD), a disorder causing involuntary movements. In this trial, participants will take valbenazine once daily for 24 weeks. Studies have found that people taking valbenazine experience significant improvements in both physical and emotional health. Specifically, they report a better quality of life and improved daily functioning, along with fewer movement symptoms. Long-term use of valbenazine has proven safe, with ongoing improvements. Additionally, it has been effective for both older and younger adults with TD. ^{4 6 7 8 9}

Who Is on the Research Team?

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Are You a Good Fit for This Trial?

Adults over 18 with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder who have been diagnosed with at least mild neuroleptic-induced tardive dyskinesia (TD) for 3+ months. Not suitable for those currently unaffected by TD symptoms.

Inclusion Criteria

Key

I am 18 years old or older.

I was diagnosed with schizophrenia, bipolar disorder, or major depression over 3 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive valbenazine once daily

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Valbenazine

Trial Overview The trial is testing Valbenazine's effectiveness on both clinician- and patient-reported outcomes in adults with TD who are either still taking or have stopped a VMAT2 inhibitor treatment.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40265997/

Improvements Over Time with Valbenazine in Elderly ... Valbenazine was safe and effective in elderly adults who received up to 48 weeks of treatment. Long-term treatment led to substantial and sustained TD ...

2. neurocrine.gcs-web.com neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-breadth-data-demonstrating

Release Details - Neurocrine Biosciences Results showed consistent improvements across all items, suggesting treatment with INGREZZA improved TDIS scores for both physical and socio- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05859698

NCT05859698 | Study of the Effectiveness of Valbenazine ... This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and ...

4. neurologylive.com neurologylive.com/view/valbenazine-linked-to-better-physical-emotional-well-being-tardive-dyskinesia

Valbenazine Linked to Better Physical and Emotional Well ... Valbenazine significantly improved physical, social, and emotional outcomes in tardive dyskinesia patients, as shown in the KINECT-PRO phase 4 ...

5. medcentral.com medcentral.com/neurology/tardive-dyskinesia/valbenazine-phase-3-study-confirms-safety-efficacy-for-tardive-dyskinesia

Valbenazine Phase 3 Study Confirms Safety, Efficacy for ... Valbenazine can be a safe, tolerable, and highly effective long-term treatment option for people with tardive dyskinesia (TD), according to the results of a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39186921/

A Post Hoc Analysis of the J-KINECT Study Conclusions: The findings suggest that valbenazine may be used effectively and safely as a treatment for TD, even in elderly patients. Trial ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748119301435

SAFETY RESULTS FROM 3 LONG-TERM VALBENAZINE ... These results confirm that valbenazine is generally safe and well-tolerated in all adults with TD.

8. neurology.org neurology.org/doi/10.1212/WNL.88.16_supplement.P2.017

Safety and Tolerability of Valbenazine (NBI-98854) in ... Valbenazine was well tolerated in adults with TD who received up to 48 weeks of treatment. TEAEs observed with long-term exposure were ...

9. psychiatrist.com psychiatrist.com/jcp/improvements-over-time-valbenazine-elderly-adults-tardive-dyskinesia-post-hoc-analyses-2-long-term-studies/

Improvements Over Time with Valbenazine in Elderly ... Conclusion: Valbenazine was safe and effective in elderly adults who received up to 48 weeks of treatment. Long-term treatment led to ...