Actively Recruiting
Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
Led by Virginia Commonwealth University · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Idiopathic cervical dystonia with neck muscles first and most prominently affected
- Age between 18 and 75 years
- Onset of dystonia symptoms at age 18 or older with no known genetic mutations related to movement disorders
- Toronto Western Spasmodic Torticollis Rating Scale-2 Motor Severity score between 5 and 20
- Stable botulinum toxin injections for at least the last 90 days with dose changes less than 10% and stable response over last two cycles
- Stable on other neuroactive medications
You will not qualify if you...
- History of deep brain stimulation
- History of uncontrolled or untreated depression in the past 3 months, suicidality, or suicide attempts
- History of uncontrolled liver disease or liver failure
- History of tardive dyskinesia or tardive dystonia
- Current use of dopaminergic or anti-dopaminergic medications including VMAT2 inhibitors or other antipsychotics
- Use of dopaminergic or anti-dopaminergic medications including VMAT2 inhibitors or other antipsychotics within the last 30 days
- Presence of parkinsonism or other movement disorders besides dystonia
- Receiving botulinum toxin injections more or less frequently than every 3 months, specifically intervals less than 11 weeks or greater than 13 weeks
- Known history of long QT syndrome, cardiac tachyarrhythmia, or significant cardiac abnormalities
- Prolonged QTc interval over 450 msec for men and over 470 msec for women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
A
Ananna Zaman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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