NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
NCT ID: NCT01688037
Last Updated: 2017-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2012-09-30
2013-10-31
Brief Summary
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Detailed Description
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The double-blind placebo-controlled treatment period the study has three arms:
* NBI-98854 50 mg once daily for 6 weeks
* NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4 weeks
* placebo
At the end of the 6-week placebo-controlled double-blind treatment period, subjects will continue in the study for an additional 6-week open-label period where all subjects who have completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and four weeks after the last dose of study drug, follow-up assessments will be performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NBI-98854 50 mg
NBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.
NBI-98854
25 mg capsule
NBI-98854 100 mg and 50 mg
NBI-98854 100 mg administered as two (2) 50 mg capsules taken every morning between 7:00am - 10:00am for 2 weeks. After 2 weeks, NBI-98854 50 mg administered by two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for remaining 4 weeks.
NBI-98854
25 mg capsule
NBI-98854
50 mg capsule
Placebo
Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
Placebo
Interventions
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NBI-98854
25 mg capsule
NBI-98854
50 mg capsule
Placebo
Eligibility Criteria
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Inclusion Criteria
* Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.
* Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
* Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
* Female subjects must not be pregnant.
* Be in good general health and expected to complete the clinical study as designed.
* Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
* Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.
* Have a negative alcohol breath test at screening and study start.
Exclusion Criteria
* Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary).
* Have a known history of neuroleptic malignant syndrome.
* Have a significant risk of suicidal or violent behavior.
* Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine.
* Receiving medication for the treatment of tardive dyskinesia.
* Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
* Have had previous exposure with NBI-98854.
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: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Little Rock, Arkansas, United States
Anaheim, California, United States
Carson, California, United States
Colton, California, United States
Costa Mesa, California, United States
Downey, California, United States
Fountain Valley, California, United States
Glendale, California, United States
National City, California, United States
Oceanside, California, United States
Paramount, California, United States
San Bernardino, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Lauderhill, Florida, United States
Melbourne, Florida, United States
Miami Springs, Florida, United States
North Miami, Florida, United States
Orange City, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Schaumburg, Illinois, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Glen Burnie, Maryland, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Toms River, New Jersey, United States
Albany, New York, United States
Brooklyn, New York, United States
Wards Island, New York, United States
Hope Mills, North Carolina, United States
Beachwood, Ohio, United States
Oklahoma City, Oklahoma, United States
Conshohocken, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
DeSoto, Texas, United States
Irving, Texas, United States
Bothell, Washington, United States
Kirkland, Washington, United States
Spokane, Washington, United States
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.
Other Identifiers
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NBI-98854-1201
Identifier Type: -
Identifier Source: org_study_id