A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
NCT ID: NCT02274558
Last Updated: 2017-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2014-10-31
2016-07-31
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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NBI-98854 40 mg
NBI-98854 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.
NBI-98854
NBI-98854 40 mg capsules
Placebo
NBI-98854 placebo capsules
NBI-98854 80 mg
Subjects randomized to the NBI-98854 80 mg dose will receive NBI-98854 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by NBI-98854 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning between 7:00am - 10:00am for 5 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.
NBI-98854
NBI-98854 40 mg capsules
Placebo
NBI-98854 placebo capsules
Placebo
Placebo administered as two (2) placebo capsules, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and be randomized to either a 40 mg or 80 mg dose. Subjects re-randomized to receive NBI-98854 80 mg will receive 40 mg for the first week.
NBI-98854
NBI-98854 40 mg capsules
Placebo
NBI-98854 placebo capsules
Interventions
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NBI-98854
NBI-98854 40 mg capsules
Placebo
NBI-98854 placebo capsules
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 good general health.
8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, phencyclidine, cocaine, opiates, or cannabinoids
Exclusion Criteria
2. Have a known history of substance dependence, or 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 of screening (some exceptions allowed)
7. Have received an investigational drug within 30 days prior to 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. Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
11. 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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Principal Investigators
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Chris O'Brien, MD
Role: PRINCIPAL_INVESTIGATOR
Neurocrine Biosciences
Locations
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Little Rock, Arkansas, United States
Anaheim, California, United States
Glendale, California, United States
Irvine, California, United States
Long Beach, California, United States
Los Angeles, California, United States
National City, California, United States
Norwalk, California, United States
Oakland, California, United States
Oceanside, California, United States
San Bernardino, California, United States
San Diego, California, United States
Torrance, California, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Kissimmee, Florida, United States
Leesburg, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
North Miami, Florida, United States
Chicago, Illinois, United States
Oak Brook, Illinois, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Glen Burnie, Maryland, United States
Worcester, Massachusetts, United States
Flowood, Mississippi, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Amherst, New York, United States
Cedarhurst, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Pinehurst, North Carolina, United States
Dayton, Ohio, United States
Shaker Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Conshohocken, Pennsylvania, United States
Norristown, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Scranton, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
DeSoto, Texas, United States
Fort Worth, Texas, United States
Irving, Texas, United States
Petersburg, Virginia, United States
Spokane, Washington, United States
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Caguas, , Puerto Rico
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.
Correll CU, Cutler AJ, Kane JM, McEvoy JP, Liang GS, O'Brien CF. Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study. J Clin Psychiatry. 2018 Dec 18;80(1):18m12278. doi: 10.4088/JCP.18m12278.
Factor SA, Remington G, Comella CL, Correll CU, Burke J, Jimenez R, Liang GS, O'Brien CF. The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. J Clin Psychiatry. 2017 Nov/Dec;78(9):1344-1350. doi: 10.4088/JCP.17m11777.
Grigoriadis DE, Smith E, Hoare SRJ, Madan A, Bozigian H. Pharmacologic Characterization of Valbenazine (NBI-98854) and Its Metabolites. J Pharmacol Exp Ther. 2017 Jun;361(3):454-461. doi: 10.1124/jpet.116.239160. Epub 2017 Apr 12.
Hauser RA, Factor SA, Marder SR, Knesevich MA, Ramirez PM, Jimenez R, Burke J, Liang GS, O'Brien CF. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484. doi: 10.1176/appi.ajp.2017.16091037. Epub 2017 Mar 21.
Other Identifiers
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NBI-98854-1304
Identifier Type: -
Identifier Source: org_study_id
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