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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Valbenazine
  • Placebo

Treatment groups

20 Participants
are divided into 2 treatment groups