Clinical trial NCT05157100: Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia
Official title: Prospective, Open-label Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Dystonia
Lead sponsor: The Orthopedic Foundation
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Experimental
Primary purpose: TREATMENT

Brief summary: Study of Ingrezza (Valbenazine) for the treatment of cervical dystonia.

Detailed description: The study will be an open-label, prospective study. Patients with a diagnosis of cervical dystonia will undergo 4 weeks of baseline evaluation, followed by a 12-week treatment period. Subjects will be evaluated in-clinic every 4 weeks. Standardized assessments will be performed at these visits. Data will also be collected from wearable IMUs (inertial measurement units) and analyzed for improvements in involuntary, repetitive movements and postures.

Eligibility criteria: Inclusion Criteria:

* Male or female patients between 18 and 85 years of age (inclusive)
* A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) by investigator for at least six months
* Moderate to severe head tremor and/or dystonic posturing as judged by the investigator
* Stable Botulinum Toxin (Botox, Dysport, Xeomin, or Myobloc) therapy dosage for at least 3 months prior to baseline visit

Exclusion Criteria

* Tardive dyskinesia
* Predominant anterocollis
* Concomitant use of strong CYP3A4 inhibitors (i.e. itraconazole, ketoconazole, clarithromycin), digoxin, strong CYP2D6 inhibitors (i.e. paroxetine, fluoxetine, quinidine), monoamine oxidase inhibitors (i.e. isocarboxazid, phenelzine, selegiline)
* Myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation)
* Diagnosis of Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
* Moderate to severe hepatic impartment as determined by a Child-Hugh Score ≥7
* Marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome
* Any conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
* Participation in another interventional study during participation in this study
* Pregnant or lactating females, or females of child-bearing potential not willing to use an acceptable method of contraception
* History of hypersensitivity to valbenazine or any components of INGREZZA.
* Is suicidal at screening as defined by below:

  1. According to the C-SSRS, he or she must not be actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline) (including, an answer of "yes" to C-SSRS questions 4 or 5 \[current or over the last 6 months\]) and must not have attempted suicide in the 1 year prior to Visit 1 (Screening); OR
  2. The subject is actively suicidal in the Investigator's judgment

Primary outcomes:
measure: Change in incidence of pain/spasm
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Albany
country: United States
facility: The Orthopedic foundation
state: Ohio
Study officials:
affiliation: principle investigator
name: Martin Taylor, DO, PHD
role: PRINCIPAL_INVESTIGATOR
References: