Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
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
1 other identifier
interventional
135
2 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2019
Shorter than P25 for phase_4
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2019
CompletedFirst Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedResults Posted
Study results publicly available
March 10, 2021
CompletedApril 20, 2021
March 1, 2021
9 months
March 25, 2019
February 16, 2021
March 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 8, Week 16
Secondary Outcomes (2)
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16
Baseline, Week 16
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Week 16
Baseline, Week 16
Study Arms (3)
Open-label Valbenazine
EXPERIMENTALParticipants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period.
Placebo-controlled Placebo
PLACEBO COMPARATORParticipants 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.
Placebo-controlled Valbenazine
EXPERIMENTALParticipants 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.
Interventions
vesicular monoamine transporter 2 (VMAT2) inhibitor
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Neurocrine Clinical Site
Little Rock, Arkansas, 72211, United States
Neurocrine Clinical Site
Anaheim, California, 92804, United States
Neurocrine Clinical Site
Anaheim, California, 92805, United States
Neurocrine Clinical Site
Costa Mesa, California, 92627, United States
Neurocrine Clinical Site
Escondido, California, 92056, United States
Neurocrine Clinical Site
Fountain Valley, California, 92708, United States
Neurocrine Clinical Site
Glendale, California, 91206, United States
Neurocrine Clinical Site
La Habra, California, 90631, United States
Neurocrine Clinical Site
Lemon Grove, California, 91945, United States
Neurocrine Clinical Site
Norwalk, California, 90650, United States
Neurocrine Clinical Site
San Bernardino, California, 92408, United States
Neurocrine Clinical Site
San Diego, California, 92108, United States
Neurocrine Clinical Site
Torrance, California, 90502, United States
Neurocrine Clinical Site
Pueblo, Colorado, 81003, United States
Neurocrine Clinical Site
Hialeah, Florida, 33012, United States
Neurocrine Clinical Site
Hialeah, Florida, 33013, United States
Neurocrine Clinical Site
Hialeah, Florida, 33018, United States
Neurocrine Clinical Site
Miami, Florida, 33183, United States
Neurocrine Clinical Site
North Miami, Florida, 33161, United States
Neurocrine Clinical Site
Orlando, Florida, 32803, United States
Neurocrine Clinical Site
South Bend, Indiana, 46601, United States
Neurocrine Clinical Site
Bloomfield Hills, Michigan, 48302, United States
Neurocrine Clinical Site
East Lansing, Michigan, 48824, United States
Neurocrine Clinical Site
Grand Rapids, Michigan, 49503, United States
Neurocrine Clinical Site
Kansas City, Missouri, 64108, United States
Neurocrine Clinical Site
St Louis, Missouri, 63109, United States
Neurocrine Clinical Site
Lincoln, Nebraska, 68526, United States
Neurocrine Clinical Site
Las Vegas, Nevada, 89102, United States
Neurocrine Clinical Site
New York, New York, 10029, United States
Neurocrine Clinical Site
Beachwood, Ohio, 44122, United States
Neurocrine Clinical Site
Mason, Ohio, 45040, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112, United States
Neurocrine Clinical Site
Conshohocken, Pennsylvania, 19428, United States
Neurocrine Clinical Site
Scranton, Pennsylvania, 18503, United States
Neurocrine Clinical Site
Franklin, Tennessee, 37067, United States
Neurocrine Clinical Site
DeSoto, Texas, 75115, United States
Neurocrine Clinical Site
Houston, Texas, 44030, United States
Neurocrine Clinical Site
Houston, Texas, 77058, United States
Neurocrine Clinical Site
Irving, Texas, 75062, United States
Neurocrine Clinical Site
Richmond, Texas, 77407, United States
Neurocrine Clinical Site
Petersburg, Virginia, 23805, United States
Neurocrine Clinical Site
Spokane, Washington, 99202, United States
Neurocrine Clinical Site
San Juan, PR, 00926, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neurocrine Medical Information
- Organization
- Neurocrine Biosciences
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Chief Medical Officer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2019
First Posted
March 27, 2019
Study Start
March 18, 2019
Primary Completion
December 23, 2019
Study Completion
January 30, 2020
Last Updated
April 20, 2021
Results First Posted
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share