Recruiting
Phase 2

Valbenazine with Botulinum Toxin

Sponsor:

Virginia Commonwealth University

Code:

NCT06771323

Conditions

Cervical Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Valbenazine

Placebo

Study Details

Brief summary:

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.

Conditions

Cervical Dystonia

Study ID

NCT06771323

Start date

Dec 17, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Placebo for their initial injection cycle then switch onto Valbenazine for next injections.

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)

experimental: Albenazine for the first injection cycle then switch to Placebo for next injections

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).

Interventions

Valbenazine

To assess if valbenazine 80mg daily improves motor symptoms in idiopathic CD patients with persistent symptoms despite current treated with botulinum toxin injections.

Placebo

Placebo

Primary outcome measure

  • Toronto Western Spasmodic Torticollis Rating Scale-2 (TWSTRS)-severity score change at 12 weeks of treatment [ Time Frame: baseline and 12 weeks of treatment ]

Central Contacts and Locations

Central contacts

Ananna Zaman

8043686610Ananna.Zaman@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Caileigh Dintino

804-220-0970caileigh.dintino@vcuhealth.org

Brian Berman

(804)-628-5276bermanbd2@vcu.edu

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-06-04.