Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
NCT ID: NCT02679079
Last Updated: 2021-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2016-03-23
2017-04-14
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
Administered once daily for 6 weeks
Placebo
Dose Group 1
Administered once daily for 6 weeks
NBI-98854
Dose Group 2
Administered once daily for 6 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. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids 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 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 blood loss ≥250 mL or donated blood within 30 days prior to screening
7. Have a known history of substance dependence, substance (drug) or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
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
6 Years
17 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Locations
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Sun City, Arizona, United States
Springdale, Arkansas, United States
Long Beach, California, United States
San Bernardino, California, United States
San Diego, California, United States
Upland, California, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Loxahatchee Groves, Florida, United States
Melbourne, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Naperville, Illinois, United States
Wichita, Kansas, United States
Boston, Massachusetts, United States
Natick, Massachusetts, United States
Ann Arbor, Michigan, United States
Bloomfield Hills, Michigan, United States
Lincoln, Nebraska, United States
Nashua, New Hampshire, United States
Marlton, New Jersey, United States
Summit, New Jersey, United States
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Franklin, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
DeSoto, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Kirkland, Washington, United States
Seattle, 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-98854-1501
Identifier Type: -
Identifier Source: org_study_id
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