Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia

The Orthopedic Foundation

Status and phase

Completed

Phase 4

Conditions

Cervical Dystonia

Treatments

Drug: Ingrezza Pill

Study type

Interventional

Funder types

Other

Identifiers

NCT05157100

1002

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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