Clinical trial NCT03891862: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tardive Dyskinesia (TD)
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16
timeFrame: Week 8, Week 16
Secondary outcomes:
measure: Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Costa Mesa
country: United States
facility: Neurocrine Clinical Site
state: California
city: Escondido
country: United States
facility: Neurocrine Clinical Site
state: California
city: Fountain Valley
country: United States
facility: Neurocrine Clinical Site
state: California
city: Glendale
country: United States
facility: Neurocrine Clinical Site
state: California
city: La Habra
country: United States
facility: Neurocrine Clinical Site
state: California
city: Lemon Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Norwalk
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Bernardino
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: Torrance
country: United States
facility: Neurocrine Clinical Site
state: California
city: Pueblo
country: United States
facility: Neurocrine Clinical Site
state: Colorado
city: Hialeah
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: North Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Orlando
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: South Bend
country: United States
facility: Neurocrine Clinical Site
state: Indiana
city: Bloomfield Hills
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: East Lansing
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: Grand Rapids
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: Kansas City
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Saint Louis
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Lincoln
country: United States
facility: Neurocrine Clinical Site
state: Nebraska
city: Las Vegas
country: United States
facility: Neurocrine Clinical Site
state: Nevada
city: New York
country: United States
facility: Neurocrine Clinical Site
state: New York
city: Beachwood
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Mason
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Neurocrine Clinical Site
state: Oklahoma
city: Conshohocken
country: United States
facility: Neurocrine Clinical Site
state: Pennsylvania
city: Scranton
country: United States
facility: Neurocrine Clinical Site
state: Pennsylvania
city: Franklin
country: United States
facility: Neurocrine Clinical Site
state: Tennessee
city: DeSoto
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Irving
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Richmond
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Petersburg
country: United States
facility: Neurocrine Clinical Site
state: Virginia
city: Spokane
country: United States
facility: Neurocrine Clinical Site
state: Washington
city: San Juan
country: Puerto Rico
facility: Neurocrine Clinical Site
Study officials:
affiliation: Chief Medical Officer
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: