Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
NCT ID: NCT05654870
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2023-01-05
2023-11-08
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
QUADRUPLE
Study Groups
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Valbenazine
Valbenazine once daily
Valbenazine
Oral treatment
Placebo
Placebo once daily
Placebo
Placebo matching valbenazine
Interventions
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Valbenazine
Oral treatment
Placebo
Placebo matching valbenazine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is receiving a stable regimen of background antipsychotic medication
* Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay
* Participant is an outpatient with stable symptomatology
* Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse)
Exclusion Criteria
* Have a clinically significant unstable medical condition in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
* Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors
13 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
San Jose, California, United States
Neurocrine Clinical Site
Coral Gables, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Countries
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Other Identifiers
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NBI-98854-ATS3020
Identifier Type: -
Identifier Source: org_study_id
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