Using Valbenazine with Botulinum Toxin for Cervical Dystonia

Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia

This study is testing if adding a medication called valbenazine to botulinum toxin injections can help people with cervical dystonia feel better and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Virginia Commonwealth University (Academic / other)
• Locations: 1 site (Richmond, Virginia)
• Trial ID: NCT06771323 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of valbenazine as an additional treatment alongside botulinum toxin injections for patients with cervical dystonia. Cervical dystonia is a painful condition affecting neck muscles, and current treatment options are limited and often only partially effective. Participants will receive either valbenazine or a placebo while being monitored for improvements in symptoms and quality of life. The study aims to determine if valbenazine can enhance the effects of botulinum toxin and provide better relief for patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with idiopathic cervical dystonia who have stable responses to botulinum toxin injections.

Not a fit: Patients with a history of deep brain stimulation or uncontrolled depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptom relief and quality of life for patients with cervical dystonia.

How similar studies have performed: While there have been limited studies on valbenazine for dystonia, its use in other movement disorders shows promise, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Idiopathic CD (neck musculature first and most prominently affected)
* 18-75 years old (participants excluded if their dystonia symptoms began before age 18 as childhood-onset dystonia typically represents a genetic and/or primary generalized form of dystonia)
* Onset of dystonia ≥18 years old, no known hyperkinetic movement disorder-related genetic mutation
* Dystonia severity more than minimal and not very severe as defined by Toronto Western Spasmodic Torticollis Rating Scale-2 Motor Severity (TWSTRS-2-Severity) score ≥ 5 and ≤ 20.
* Stable on botulinum toxin injections last 90 days (BoNT dose change \<10% and patient reported stability of response over last two injection cycles)
* Stable on other neuroactive medications.

Exclusion Criteria:

* History of deep brain stimulation
* History of uncontrolled or untreated depression in the prior 3 months, suicidality, or history of suicide attempts
* History of uncontrolled liver disease or failure
* History of tardive dyskinesia or tardive dystonia
* Currently taking dopaminergic and/or anti-dopaminergic medications including VMAT2 inhibitors or other antipsychotic medications
* Exposure to dopaminergic and/or anti-dopaminergic medications including VMAT2 inhibitors or other antipsychotic medications in the last 30 days -Presence of parkinsonism or other movement disorder other than dystonia on exam -Receiving botulinum toxin injections at a planned frequency other than every 3 months or typically receive injections at intervals \<11 weeks or \>13 weeks -Known history of long QT syndrome or cardiac tachyarrhythmia or any clinically significant cardiac abnormality.
* Prolonged QTc as defined by \> 450 msec for men and \> 470 msec for women

Where this trial is running

Richmond, Virginia

• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Brian Berman — Virginia Commonwealth University
• Study coordinator: Ananna Zaman

Conditions Cervical Dystonia