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NCT06771323 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
A Phase 2 study of Cervical Dystonia, sponsored by Virginia Commonwealth University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06771323: Recruiting Phase 2 study of Cervical Dystonia, sponsored by Virginia Commonwealth University.
NCT06771323 is a Phase 2 study of Cervical Dystonia that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 20 participants, below the 86-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06771323, a Phase 2 study of Cervical Dystonia, is actively recruiting participants, sponsored by Virginia Commonwealth University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
TWSTRS-2-severity score change at 12 weeks of treatment. The isolated TWSTRS-2-Severity score change was chosen as the primary outcome because the TWSTRS-2-Severity had items dropped from the original TWSTRS as they failed to meet criteria for utility in clinimetric testing,11 and because the primary effect of Valbenazine is expected to be on the motor symptoms and less on pain and disability. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-2) uses the following scoring system for
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Valbenazine
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-12-17 |
| Est. Completion | 2026-01 |
| Phase | Phase 2 |
What NCT06771323 shows while recruiting
NCT06771323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 86-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Cervical Dystonia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06771323 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06771323 about?
NCT06771323 is a clinical study titled "Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia". 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 o...
What is the current status of trial NCT06771323?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-12-17. Estimated completion is 2026-01.
What conditions does trial NCT06771323 study?
This clinical trial studies the following conditions: Cervical Dystonia.
What interventions are being tested in trial NCT06771323?
The interventions under investigation include: Placebo (DRUG), Valbenazine (DRUG).
Who is sponsoring clinical trial NCT06771323?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06771323 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06771323's enrollment target sits among peer trials
20 13th of 15 the lowest of 15 other Cervical Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Dystonia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
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