Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
NCT ID: NCT02736955
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
161 participants
INTERVENTIONAL
2016-06-13
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Valbenazine
Fixed dose of valbenazine administered once daily for up to 72 weeks
Valbenazine
Interventions
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Valbenazine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.
* If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.
* Be in general good health.
* Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Exclusion Criteria
* Have a known history of substance dependence, substance (drug) or alcohol abuse.
* Have a significant risk of suicidal or violent behavior.
* Have a known history of neuroleptic malignant syndrome.
* Have a known history of long QT syndrome or cardiac arrhythmia.
* Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than valbenazine) during the study.
* Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
* Are currently pregnant or breastfeeding.
18 Years
85 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Locations
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Anaheim, California, United States
National City, California, United States
Norwalk, California, United States
Oakland, California, United States
San Bernardino, California, United States
San Diego, California, United States
Torrance, California, United States
Hialeah, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Shreveport, Louisiana, United States
Worcester, Massachusetts, United States
Cedarhurst, New York, United States
Dayton, Ohio, United States
Shaker Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Norristown, Pennsylvania, United States
Charleston, South Carolina, United States
Franklin, Tennessee, United States
Memphis, Tennessee, United States
DeSoto, Texas, United States
Fort Worth, Texas, United States
Irving, Texas, United States
Salt Lake City, Utah, United States
Petersburg, Virginia, United States
Spokane, Washington, United States
Countries
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References
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Lindenmayer JP, Verghese C, Marder SR, Burke J, Jimenez R, Siegert S, Liang GS, O'Brien CF. A long-term, open-label study of valbenazine for tardive dyskinesia. CNS Spectr. 2021 Aug;26(4):345-353. doi: 10.1017/S109285292000108X. Epub 2020 May 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NBI-98854-1506
Identifier Type: -
Identifier Source: org_study_id