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

Prospective, Open-label Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia

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

Study Overview

• Status: Completed
• Conditions: Cervical Dystonia
• Intervention / Treatment: Drug: Ingrezza Pill

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • New Albany, Ohio, United States, 43054
      • The Orthopedic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ingrezza; Participants will receive Ingrezza orally once daily for 12 weeks.	Drug: Ingrezza Pill; Participants will receive Ingrezza 40 mg and 80 mg tablets for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in incidence of pain/spasm	Change in incidence rate of pain/spasm as measured by frequency and intensity in subjects prior to and during use of valbenazine as measured by Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Inertial measurement unit (IMU). TWSTRS is a composite scale used to measure three aspects of CD: severity, disability, and pain. TWSTRS total score falls within the range of 0 to 85, where a higher score indicates a more severe condition.	16 weeks

Collaborators and Investigators

• Sponsor: The Orthopedic Foundation
• Investigators: Principal Investigator: Martin Taylor, DO, PHD, principle investigator

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Torticollis
• Other Study ID Numbers: 1002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes