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

NCT05157100 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 1002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ingrezza

EXPERIMENTAL

Participants will receive Ingrezza orally once daily for 12 weeks.

Drug: Ingrezza Pill

Interventions

Ingrezza Pill DRUG

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

Ingrezza

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• The subject is actively suicidal in the Investigator's judgment

Sponsors & Collaborators

• The Orthopedic Foundation: lead

Study Sites (1)

The Orthopedic foundation

New Albany, Ohio, 43054, United States

Location

MeSH Terms

Conditions

Torticollis

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Taylor, DO, PHD

  principle investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: October 19, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (1)