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

NCT ID: NCT05157100

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2023-09-15

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.

Conditions

Cervical Dystonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ingrezza

Participants will receive Ingrezza orally once daily for 12 weeks.

Group Type: EXPERIMENTAL

Ingrezza Pill

Intervention Type: DRUG

Participants will receive Ingrezza 40 mg and 80 mg tablets for 12 weeks.

Interventions

Ingrezza Pill

Participants will receive Ingrezza 40 mg and 80 mg tablets for 12 weeks.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Orthopedic Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Taylor, DO, PHD

Role: PRINCIPAL_INVESTIGATOR

principle investigator

Locations

The Orthopedic foundation

New Albany, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

1002

Identifier Type: -

Identifier Source: org_study_id