Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Orthopedic Foundation

Must be taking: Botulinum toxin

Must not be taking: Strong CYP3A4 inhibitors, Digoxin

Disqualifiers: Tardive dyskinesia, Neuromuscular disease, 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: 3

Duration: 12 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications, like strong CYP3A4 inhibitors, digoxin, strong CYP2D6 inhibitors, and monoamine oxidase inhibitors. If you are on these, you may need to stop them to participate.

What is the purpose of this trial?

This trial is testing Ingrezza, a medication that may help people with cervical dystonia, a condition causing involuntary neck movements. The study will last a few months and involve periodic check-ups. The medication works by balancing brain chemicals to improve muscle control.

Research Team

Martin Taylor, DO, PHD

Principal Investigator

principle investigator

Eligibility Criteria

Inclusion Criteria

A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) by investigator for at least six months

Moderate to severe head tremor and/or dystonic posturing as judged by the investigator Stable Botulinum Toxin (Botox, Dysport, Xeomin, or Myobloc) therapy dosage for at least 3 months prior to baseline visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Baseline evaluation

Treatment

Participants receive Ingrezza orally once daily for 12 weeks

12 weeks

3 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ingrezza

Participant Groups

Group I: Ingrezza Experimental Treatment 1 Intervention

Participants will receive Ingrezza orally once daily for 12 weeks.

Who Is Running the Clinical Trial?

The Orthopedic Foundation

Lead Sponsor

Trials

1

Recruited

20+