drugset / Trial / NCT06771323

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

NCT06771323

Phase 2 Recruiting 20 enrolled Virginia Commonwealth University
RandomizedCrossoverTriple-blindTreatment

Summary

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.

Timeline

Start
2024-12-17
Primary completion
2027-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Valbenazine Small molecule 80 mg

Indications