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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16
Secondary Outcome
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16
Condition
Tardive Dyskinesia (TD)
Intervention
Valbenazine
Study Arms / Comparison Groups
Open-label Valbenazine
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
135
Start Date
March 18, 2019
Completion Date
January 30, 2020
Primary Completion Date
December 23, 2019
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. Have one of the following clinical diagnoses for at least 3 months before screening:
Schizophrenia, Schizoaffective Disorder, or Mood Disorder
3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before
screening.
4. 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.
5. Be in general good health.
6. Have adequate hearing, vision, and language skills to perform the procedures specified
in the protocol.
Exclusion Criteria:
1. Have an active, clinically significant unstable medical condition within 1 month
before screening.
2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
3. Have a significant risk of suicidal or violent behavior.
4. Have been hospitalized for psychiatric disorder within 6 months before Day 1.
5. Have a known history of neuroleptic malignant syndrome.
6. Have a known history of long QT syndrome or cardiac arrhythmia.
7. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
8. Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine
(INGREZA) within 30 days of screening.
9. 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.
10. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
11. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg,
tetrabenazine, deutetrabenazine).
12. Are currently pregnant or breastfeeding.
13. Have HIV or hepatitis B.
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Chief Medical Officer, ,
Location Countries
Puerto Rico
Location Countries
Puerto Rico
Administrative Informations
NCT ID
NCT03891862
Organization ID
NBI-98854-TD4002
Responsible Party
Sponsor
Study Sponsor
Neurocrine Biosciences
Study Sponsor
Chief Medical Officer, Study Director, Chief Medical Officer
Verification Date
March 2021