Using Valbenazine with Botulinum Toxin for Cervical Dystonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Brian Berman — Virginia Commonwealth University
• Study coordinator: Ananna Zaman
• Email: Ananna.Zaman@vcuhealth.org
• Phone: 8043686610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted Focused Ultrasound for Cervical Dystonia

  This trial tests whether applying theta burst focused ultrasound to brain regions GPi or DN, or a sham, can help people with cervical dystonia.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07690514

• Noninvasive brain stimulation for cervical dystonia using continuous theta-burst in a sham-controlled trial

  This study tests whether delivering continuous theta-burst stimulation to the brain can reduce neck dystonia symptoms compared with sham stimulation.

  Recruiting Fondazione Policlinico Universitario Campus Bio-Medico · Roma, Roma · NCT07681284

• Vibration to improve head posture in cervical dystonia

  This trial will test whether stronger vibration applied to the neck muscles helps correct abnormal head posture in people with cervical dystonia.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07245615

• Adding zinc to Botox for cervical dystonia

  This will test whether taking daily zinc citrate after a Botox injection helps people with cervical dystonia keep symptom relief longer.

  Recruiting Phase 2 University of Florida · Gainesville, Florida · NCT07140874

• IPN10200 treatment for cervical dystonia in adults

  This trial will test whether a single injection of IPN10200 (one of two doses) reduces neck posture problems, pain, and disability better than placebo in adults with cervical dystonia.

  Recruiting at 27 sites Phase 2 Ipsen · Tucson, Arizona and 44 other locations · NCT06937931

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.