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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion pushed from May 2026 to Jun 2027v7
  2. Primary and study completion pushed from Apr 2026 to May 2026v6
  3. Primary and study completion dates: Jan 2026 to Apr 2026v5
  4. Collaborators shortened, about 2 wordsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2025 to Dec 17, 2024
    • Site details revised
    v3
  6. Start date: Jan 2025 to Mar 2025v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06771323
Lead Sponsor Virginia Commonwealth University
Conditions
(from sponsor)		 Cervical Dystonia
Related terms Torticollis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov