Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
NCT ID: NCT02581865
Last Updated: 2020-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2015-11-30
2016-12-31
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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Placebo
Placebo administered once daily for 8 weeks
Placebo
Dose Group 1
Fixed dose administered once daily for 8 weeks
NBI-98854
Dose Group 2
Fixed dose administered once daily for 8 weeks
NBI-98854
Interventions
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NBI-98854
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
5. Be in good general health
6. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen
7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
Exclusion Criteria
2. Have a known history of long QT syndrome or cardiac tachy-arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a known history of substance dependence, substance (drug) or alcohol abuse
7. Have a significant risk of suicidal or violent behavior
8. Are currently pregnant or breastfeeding
9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
11. Have a blood loss ≥550 mL or donated blood within 30 days prior to screening
18 Years
64 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Locations
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Long Beach, California, United States
National City, California, United States
San Bernardino, California, United States
San Diego, California, United States
Upland, California, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Natick, Massachusetts, United States
St Louis, Missouri, United States
Nashua, New Hampshire, United States
Summit, New Jersey, United States
Albany, New York, United States
Manhasset, New York, United States
New York, New York, United States
Staten Island, New York, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Norristown, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Irving, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Kirkland, Washington, United States
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NBI-98854-1505
Identifier Type: -
Identifier Source: org_study_id
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