Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

Tardive Dyskinesia (TD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891862
• Other study ID #: NBI-98854-TD4002
• Status: Completed
• Phase: Phase 4
• Start date: March 18, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2021
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 30, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia
• Tardive Dyskinesia (TD)

Intervention

Drug:
• Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
• Placebo oral capsule
non-active dosage form

Locations

Country	Name	City	State
Puerto Rico	Neurocrine Clinical Site	San Juan
United States	Neurocrine Clinical Site	Anaheim	California
United States	Neurocrine Clinical Site	Anaheim	California
United States	Neurocrine Clinical Site	Beachwood	Ohio
United States	Neurocrine Clinical Site	Bloomfield Hills	Michigan
United States	Neurocrine Clinical Site	Conshohocken	Pennsylvania
United States	Neurocrine Clinical Site	Costa Mesa	California
United States	Neurocrine Clinical Site	DeSoto	Texas
United States	Neurocrine Clinical Site	East Lansing	Michigan
United States	Neurocrine Clinical Site	Escondido	California
United States	Neurocrine Clinical Site	Fountain Valley	California
United States	Neurocrine Clinical Site	Franklin	Tennessee
United States	Neurocrine Clinical Site	Glendale	California
United States	Neurocrine Clinical Site	Grand Rapids	Michigan
United States	Neurocrine Clinical Site	Hialeah	Florida
United States	Neurocrine Clinical Site	Hialeah	Florida
United States	Neurocrine Clinical Site	Hialeah	Florida
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Irving	Texas
United States	Neurocrine Clinical Site	Kansas City	Missouri
United States	Neurocrine Clinical Site	La Habra	California
United States	Neurocrine Clinical Site	Las Vegas	Nevada
United States	Neurocrine Clinical Site	Lemon Grove	California
United States	Neurocrine Clinical Site	Lincoln	Nebraska
United States	Neurocrine Clinical Site	Little Rock	Arkansas
United States	Neurocrine Clinical Site	Mason	Ohio
United States	Neurocrine Clinical Site	Miami	Florida
United States	Neurocrine Clinical Site	New York	New York
United States	Neurocrine Clinical Site	North Miami	Florida
United States	Neurocrine Clinical Site	Norwalk	California
United States	Neurocrine Clinical Site	Oklahoma City	Oklahoma
United States	Neurocrine Clinical Site	Orlando	Florida
United States	Neurocrine Clinical Site	Petersburg	Virginia
United States	Neurocrine Clinical Site	Pueblo	Colorado
United States	Neurocrine Clinical Site	Richmond	Texas
United States	Neurocrine Clinical Site	Saint Louis	Missouri
United States	Neurocrine Clinical Site	San Bernardino	California
United States	Neurocrine Clinical Site	San Diego	California
United States	Neurocrine Clinical Site	Scranton	Pennsylvania
United States	Neurocrine Clinical Site	South Bend	Indiana
United States	Neurocrine Clinical Site	Spokane	Washington
United States	Neurocrine Clinical Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Week 16
Secondary	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").	Baseline, Week 16