Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
NCT ID: NCT02405091
Last Updated: 2018-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
167 participants
INTERVENTIONAL
2015-03-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Group 1
Fixed dose of NBI-98854 administered once daily for 48 weeks
NBI-98854
Dose Group 2
Fixed dose of NBI-98854 administered once daily up to 48 weeks
NBI-98854
Interventions
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NBI-98854
Eligibility Criteria
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Inclusion Criteria
2. Female subjects must not be pregnant.
3. Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
5. Have moderate or severe TD
6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
7. Be in general good health.
8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
9. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.
Exclusion Criteria
2. Have a known history of substance dependence, substance (drug) 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 tachy-arrhythmia.
6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
7. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
10. 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
Glendale, California, United States
Irvine, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oakland, California, United States
San Bernardino, California, United States
San Diego, California, United States
Torrance, California, United States
Hockessin, Delaware, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Shreveport, Louisiana, United States
Natick, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Nashua, New Hampshire, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
High Point, North Carolina, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Conshohocken, Pennsylvania, United States
Norristown, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Scranton, Pennsylvania, United States
DeSoto, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Petersburg, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
San Juan, , Puerto Rico
Countries
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References
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Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NBI-98854-1402
Identifier Type: -
Identifier Source: org_study_id
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