Back to resultsPersistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Primary Purpose
Tardive Dyskinesia (TD)
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Valbenazine
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia (TD)
Eligibility Criteria
Inclusion Criteria:
- Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
- Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
- Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
- Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
- Be in general good health.
- Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Exclusion Criteria:
- Have an active, clinically significant unstable medical condition within 1 month before screening.
- Have a known history of substance (drug) dependence, or substance or alcohol abuse.
- Have a significant risk of suicidal or violent behavior.
- Have been hospitalized for psychiatric disorder within 6 months before Day 1.
- Have a known history of neuroleptic malignant syndrome.
- Have a known history of long QT syndrome or cardiac arrhythmia.
- Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
- Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
- Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
- Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
- Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
- Are currently pregnant or breastfeeding.
- Have HIV or hepatitis B.
Sites / Locations
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Open-label Valbenazine
Placebo-controlled Placebo
Placebo-controlled Valbenazine
Arm Description
Participants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period.
Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
Outcomes
Primary Outcome Measures
Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16
The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements. The AIMS Dyskinesia Total Score is the sum of items 1-7 and ranges from 0 to 28, with higher scores indicating more severe dyskinesia. Least-squares mean were estimated using a mixed-effects model for repeated measures.
Secondary Outcome Measures
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16
The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The health state index score is based on the results of the individual health profiles using the United States value set and ranges from -0.573 to 1.0, with higher scores indicating higher health utility.
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Week 16
The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 ("the worst imaginable health") to 100 ("the best imaginable health").
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03891862
Brief Title
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Official Title
A Phase 4, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
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
Yes
5. Study Description
Brief Summary
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia (TD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-label Valbenazine
Arm Type
Experimental
Arm Description
Participants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period.
Arm Title
Placebo-controlled Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
Arm Title
Placebo-controlled Valbenazine
Arm Type
Experimental
Arm Description
Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Valbenazine
Other Intervention Name(s)
Ingrezza, NBI-98854
Intervention Description
vesicular monoamine transporter 2 (VMAT2) inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
non-active dosage form
Primary Outcome Measure Information:
Title
Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16
Description
The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements. The AIMS Dyskinesia Total Score is the sum of items 1-7 and ranges from 0 to 28, with higher scores indicating more severe dyskinesia. Least-squares mean were estimated using a mixed-effects model for repeated measures.
Time Frame
Week 8, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16
Description
The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The health state index score is based on the results of the individual health profiles using the United States value set and ranges from -0.573 to 1.0, with higher scores indicating higher health utility.
Time Frame
Baseline, Week 16
Title
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Week 16
Description
The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 ("the worst imaginable health") to 100 ("the best imaginable health").
Time Frame
Baseline, Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
Be in general good health.
Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Exclusion Criteria:
Have an active, clinically significant unstable medical condition within 1 month before screening.
Have a known history of substance (drug) dependence, or substance or alcohol abuse.
Have a significant risk of suicidal or violent behavior.
Have been hospitalized for psychiatric disorder within 6 months before Day 1.
Have a known history of neuroleptic malignant syndrome.
Have a known history of long QT syndrome or cardiac arrhythmia.
Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
Are currently pregnant or breastfeeding.
Have HIV or hepatitis B.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Neurocrine Clinical Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Neurocrine Clinical Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Neurocrine Clinical Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Neurocrine Clinical Site
City
Escondido
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Neurocrine Clinical Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Neurocrine Clinical Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Neurocrine Clinical Site
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Neurocrine Clinical Site
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Neurocrine Clinical Site
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Neurocrine Clinical Site
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
Neurocrine Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Neurocrine Clinical Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Neurocrine Clinical Site
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81003
Country
United States
Facility Name
Neurocrine Clinical Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Neurocrine Clinical Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Neurocrine Clinical Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33018
Country
United States
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Neurocrine Clinical Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Neurocrine Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Neurocrine Clinical Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Neurocrine Clinical Site
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Neurocrine Clinical Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Neurocrine Clinical Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Neurocrine Clinical Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Neurocrine Clinical Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Neurocrine Clinical Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Neurocrine Clinical Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Neurocrine Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Neurocrine Clinical Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Neurocrine Clinical Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Neurocrine Clinical Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Neurocrine Clinical Site
City
Conshohocken
State/Province
Pennsylvania
ZIP/Postal Code
19428
Country
United States
Facility Name
Neurocrine Clinical Site
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
Facility Name
Neurocrine Clinical Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Neurocrine Clinical Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Neurocrine Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
44030
Country
United States
Facility Name
Neurocrine Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Neurocrine Clinical Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Neurocrine Clinical Site
City
Richmond
State/Province
Texas
ZIP/Postal Code
77407
Country
United States
Facility Name
Neurocrine Clinical Site
City
Petersburg
State/Province
Virginia
ZIP/Postal Code
23805
Country
United States
Facility Name
Neurocrine Clinical Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Neurocrine Clinical Site
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
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