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

Primary Purpose

Cervical Dystonia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ingrezza Pill
Sponsored by
The Orthopedic Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Orthopedic foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ingrezza

Arm Description

Participants will receive Ingrezza orally once daily for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2021
Last Updated
October 5, 2023
Sponsor
The Orthopedic Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05157100
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
September 15, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Orthopedic Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Experimental
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ingrezza
Arm Type
Experimental
Arm Description
Participants will receive Ingrezza orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Ingrezza Pill
Intervention Description
Participants will receive Ingrezza 40 mg and 80 mg tablets for 12 weeks.
Primary Outcome Measure Information:
Title
Change in incidence of pain/spasm
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Taylor, DO, PHD
Organizational Affiliation
principle investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Orthopedic foundation
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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