Valbenazine for Torticollis

Recruiting in Palo Alto (17 mi)

Overseen byBrian Berman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Virginia Commonwealth University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The most common form of idiopathic dystonia is adult-onset cervical dystonia (CD), a focal form of dystonia affecting the muscles of the neck. CD is often associated with pain and limited range of motion, and frequently leads to reduced quality of life and disability. Effective long-term treatment options are extremely limited. Recurring botulinum neurotoxin (BoNT) injections can ease the symptoms of CD, but they frequently provide only partial relief and can be associated with intolerable side effects. Deep brain stimulation can be used to treat more severe cases of CD, but this neurosurgical procedure is invasive, on average only about 50% effective and may lead to serious adverse effects. Novel treatment approaches for CD are desperately needed to alleviate symptoms and improve the quality of life for the many who suffer from this chronic and disabling neurological disorder.

Eligibility Criteria

This trial is for adults with cervical dystonia, a condition affecting neck muscles, causing pain and limited motion. Participants must be currently receiving botulinum toxin injections but still experiencing symptoms. Those with other forms of dystonia or who can't tolerate the study procedures are excluded.

Inclusion Criteria

My dystonia started after I turned 18 and I don't have a genetic mutation related to movement disorders.

My medication for brain or nerve conditions is not changing.

I am between 18 and 75 years old and my dystonia started after I turned 18.

+3 more

Exclusion Criteria

History of deep brain stimulation

I have a history of involuntary muscle movements or dystonia.

I get botulinum toxin shots not every 3 months but at different times.

+7 more

Participant Groups

The trial tests Valbenazine as an additional treatment to botulinum toxin injections in managing cervical dystonia symptoms. It's a randomized study where some participants will receive Valbenazine while others will get a placebo to compare effectiveness.

2Treatment groups

Experimental Treatment

Group I: Placebo for their initial injection cycle then switch onto Valbenazine for next injections.Experimental Treatment2 Interventions

Subject will receive the placebo for their initial injection cycle (for 3 months) and then switch onto Valbenazine at the time of their next injections.(next 3 months)

Group II: Albenazine for the first injection cycle then switch to Placebo for next injectionsExperimental Treatment2 Interventions

Subject will receive albenazine for the first injection cycle (duration of 3 months) and then switch onto Placebo at the time of their next injections (remain on it for the next 3 months).