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Tests treatment safety and results for Cervical Dystonia
Official title Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
ClinicalTrials.gov ID: NCT06771323
What this study is testing
What is Valbenazine?
Valbenazine is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for cervical dystonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- Stable on botulinum toxin injections last 90 days (BoNT dose change \<10% and patient reported stability of response over last two injection cycles)
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- Prolonged QTc as defined by \> 450 msec for men and \> 470 msec for women
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.