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Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Valbenazine
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: At least 18 years of age Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder Have a clinical diagnosis of neuroleptic-induced TD Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study Participants must be outpatients and have a stable psychiatric status Key Exclusion Criteria: Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit

Sites / Locations

  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valbenazine

Arm Description

Valbenazine administered once daily for 24 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24
Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24
Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24

Secondary Outcome Measures

Patient Global Impression of Change (PGI-C) score at Week 24
Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24
Change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at Week 24

Full Information

First Posted
May 5, 2023
Last Updated
August 17, 2023
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05859698
Brief Title
Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
Official Title
A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Valbenazine
Arm Type
Experimental
Arm Description
Valbenazine administered once daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Valbenazine
Other Intervention Name(s)
NBI-98854
Intervention Description
Valbenazine capsules for oral administration
Primary Outcome Measure Information:
Title
Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGI-C) score at Week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at Week 24
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: At least 18 years of age Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder Have a clinical diagnosis of neuroleptic-induced TD Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study Participants must be outpatients and have a stable psychiatric status Key Exclusion Criteria: Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neurocrine Medical Information Call Center
Phone
877-641-3461
Email
medinfo@neurocrine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Lead
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33629
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Beechwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

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