Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
NCT ID: NCT03530293
Last Updated: 2022-05-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
81 participants
INTERVENTIONAL
2018-04-17
2019-07-16
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
TRIPLE
Study Groups
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Pre-randomization Valbenazine
Participants received valbenazine once daily for up to 12 weeks, depending on if and when randomization occured. The starting dose was 20 mg for participants \<50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants \<50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Randomized Placebo
Participants received placebo (matching valbenazine) once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.
Placebo oral capsule
non-active dosage form
Randomized Valbenazine
Participants received their optimized dose of valbenazine once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Interventions
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Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo oral capsule
non-active dosage form
Other Intervention Names
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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
11. Have previously participated in an NBI-98854 clinical study, except for NBI-98854-1403 or NBI-98854-1501.
12. Have HIV, hepatitis B, or hepatitis C
6 Years
17 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neuricrine Clinical Site
Sun City, Arizona, United States
Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
Rogers, Arkansas, United States
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
Fullerton, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Santa Ana, California, United States
Neurocrine Clinical Site
Pueblo, Colorado, United States
Neurocrine Clinical Site
Stamford, Connecticut, United States
Neurocrine Clinical Site
Washington D.C., District of Columbia, United States
Neurocrine Clinical Site
Gulf Breeze, Florida, United States
Neurocrine Clinical Site
Hialeah, Florida, United States
Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
North Miami, Florida, United States
Neurocrine Clinical Site
Orlando, Florida, United States
Neurocrine Clinical Site
Palmetto Bay, Florida, United States
Neurocrine Clinical Site
Spring Hill, Florida, United States
Neurocrine Clinical Site
St. Petersburg, Florida, United States
Neurocrine Clinical Site
Tallahassee, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Fayetteville, Georgia, United States
Neurocrine Clinical Site
Savannah, Georgia, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
South Bend, Indiana, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
Bloomfield Hills, Michigan, United States
Neurocrine Clinical Site
West Bloomfield, Michigan, United States
Neurocrine Clinical Site
Lincoln, Nebraska, United States
Neurocrine Clinical Site
Nashua, New Hampshire, United States
Neurocrine Clinical Site
Cherry Hill, New Jersey, United States
Neurocrine Clinical Site
Mount Arlington, New Jersey, United States
Neurocrine Clinical Site
New York, New York, United States
Neurocrine Clinical Site
South Setauket, New York, United States
Neurocrine Clinical Site
Charlotte, North Carolina, United States
Neurocrine Clinical Site
Mason, Ohio, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
DeSoto, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Irving, Texas, United States
Neurocrine Clinical Site
San Antonio, Texas, United States
Neurocrine Clinical Site
Charlottesville, Virginia, United States
Neurocrine Clinical Site
Bothell, Washington, United States
Neurocrine Clinical Site
Everett, Washington, United States
Neurocrine Clinical Site
Spokane, Washington, United States
Neurocrine Clinical Site
San Juan, , Puerto Rico
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-TS2005
Identifier Type: -
Identifier Source: org_study_id
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