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

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called Valbenazine works alongside botulinum toxin injections to treat cervical dystonia (CD), a condition that causes painful and involuntary muscle contractions in the neck. Many people with CD find that botulinum toxin injections help, but they often experience only partial relief and may have side effects. This trial is looking for new ways to provide better long-term relief for patients with CD, aiming to improve their quality of life.

To participate in the trial, individuals must be between 18 and 75 years old and have been diagnosed with idiopathic cervical dystonia, meaning their condition has no known cause. They should also have stable symptoms while receiving botulinum toxin injections for at least 90 days. However, people with certain conditions, such as a history of deep brain stimulation or specific heart issues, cannot join. Participants can expect to receive either Valbenazine or a placebo (a non-active substance) in addition to their regular treatment, and they will be monitored closely throughout the study to assess the safety and effectiveness of the new approach.

Gender

ALL

Eligibility criteria

• 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