Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
Key facts
- Who runs it
- Virginia Commonwealth University
- Where
- Richmond, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 20 people, planned
- Started
- 17 Dec 2024
- Expected to end
- Jun 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Valbenazine
- Placebo
- Record updated
- 4 June 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of uncontrolled or untreated depression in the prior 3 months, suicidality, or history of suicide attempts
- Currently taking dopaminergic and/or anti-dopaminergic medications including VMAT2 inhibitors or other antipsychotic medications
- History of deep brain stimulation
- History of uncontrolled liver disease or failure
- History of tardive dyskinesia or tardive dystonia
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- Virginia Commonwealth UniversityRichmond, United StatesContact: Caileigh DintinoTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Placebo for their initial injection cycle then switch onto Valbenazine for next injections.Treatment being tested
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)
Treatment: Valbenazine and Placebo
- Albenazine for the first injection cycle then switch to Placebo for next injectionsTreatment being tested
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).
Treatment: Valbenazine and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06771323, who can take part
- Record updated
- 4 June 2026