Clinical trial NCT03698331: The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Official title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tardive Dyskinesia (TD)
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 potential for clinical dependence and withdrawal symptoms associated with valbenazine.


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 a known history of neuroleptic malignant syndrome.
5. Have a known history of long QT syndrome or cardiac arrhythmia.
6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
7. Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine clinical study.
8. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
9. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
10. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
11. Are currently pregnant or breastfeeding.
12. Have HIV or hepatitis B.

Primary outcomes:
measure: Participants With Withdrawal-Emergent Adverse Events
timeFrame: 3 weeks
Secondary outcomes:
measure: Participants Who Experience Worsening of Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20)
timeFrame: 3 weeks
measure: Absolute Worst Total Score as Measured by the Physician Withdrawal Checklist-20 (PWC-20)
timeFrame: 3 weeks
measure: Severity of Withdrawal Symptoms as Measured by the Change From Withdrawal Baseline (Week 4) to Week 7 in the Modified Cocaine Selective Severity Assessment (mCSSA)
timeFrame: 7 weeks
measure: Overall Improvement From Baseline of TD Symptoms as Measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) Score
timeFrame: Baseline, Week 4, Week 7
measure: Change in Severity of TD Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) Scale
timeFrame: Baseline, Week 4, Week 7
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Glendale
country: United States
facility: Neurocrine Clinical Site
state: California
city: Norwalk
country: United States
facility: Neurocrine Clinical Site
state: California
city: Oceanside
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Bernardino
country: United States
facility: Neurocrine Clinical Site
state: California
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: Honolulu
country: United States
facility: Neurocrine Clinical Site
state: Hawaii
city: Fort Wayne
country: United States
facility: Neurocrine Clinical Site
state: Indiana
city: Ann Arbor
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: Beechwood
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Neurocrine Clinical Site
state: Oklahoma
city: Scranton
country: United States
facility: Neurocrine Clinical Site
state: Pennsylvania
city: DeSoto
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Irving
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: San Juan
country: Puerto Rico
facility: Neurocrine Clinical Site
Study officials:
affiliation: Chief Medical Officer
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: