The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
NCT ID: NCT03698331
Last Updated: 2020-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
89 participants
INTERVENTIONAL
2018-09-14
2019-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Valbenazine
Valbenazine or placebo oral capsules administered once daily for 7 weeks.
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo oral capsule
non-active dosage form
Placebo
Placebo oral capsules administered once daily for 7 weeks.
Placebo oral capsule
non-active dosage form
Interventions
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Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo oral capsule
non-active dosage form
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
Glendale, California, United States
Neurocrine Clinical Site
Norwalk, California, United States
Neurocrine Clinical Site
Oceanside, California, United States
Neurocrine Clinical Site
San Bernardino, California, 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
Honolulu, Hawaii, United States
Neurocrine Clinical Site
Fort Wayne, Indiana, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
Beechwood, Ohio, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Scranton, Pennsylvania, United States
Neurocrine Clinical Site
DeSoto, Texas, United States
Neurocrine Clinical Site
Irving, Texas, United States
Neurocrine Clinical Site
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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NBI-98854-TD4001
Identifier Type: -
Identifier Source: org_study_id
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