Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
NCT ID: NCT03444038
Last Updated: 2022-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2018-02-08
2019-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Valbenazine
Valbenazine administered once daily for up to 24 weeks
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Interventions
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Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a clinical diagnosis of Tourette Syndrome (TS)
3. 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
4. Be in good general health
5. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
6. 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 vesicular monoamine transporter 2 (VMAT2) inhibitors
6. Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline
7. Have a known history of substance (drug) dependence, or substance or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. 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
18 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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Neurocrine Clinical Site
Sun City, Arizona, United States
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Santa Ana, California, United States
Neurocrine Clinical Site
Santa Clarita, California, United States
Neurocrine Clinical Site
New Haven, Connecticut, United States
Neurocrine Clinical Site
Boca Raton, Florida, United States
Neurocrine Clinical Site
Gulf Breeze, Florida, United States
Neurocrine Clinical Site
Hialeah, Florida, United States
Neurocrine Clinical Site
Orlando, Florida, United States
Neurocrine Clinical Site
Orlando, Florida, United States
Neurocrine Clinical Site
St. Petersburg, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Naperville, Illinois, United States
Neurocrine Clinical Site
Iowa City, Iowa, United States
Neurocrine Clinical Site
Leawood, Kansas, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
Bloomfield Hills, Michigan, United States
Neurocrine Clinical Site
St Louis, Missouri, United States
Neurocrine Clinical Site
Lincoln, Nebraska, United States
Neurocrine Clinical Site
Nashua, New Hampshire, United States
Neurocrine Clinical Site
Mount Arlington, New Jersey, United States
Neurocrine Clinical Site
Voorhees Township, New Jersey, United States
Neurocrine Clinical Site
New York, New York, United States
Neurocrine Clinical Site
The Bronx, New York, United States
Neurocrine Clinical Site
Durham, North Carolina, United States
Neurocrine Clinical Site
Mason, Ohio, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Charleston, South Carolina, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
San Antonio, Texas, United States
Neurocrine Clinical Site
Everett, Washington, United States
Neurocrine Clinical Site
Tacoma, Washington, United States
Neurocrine Clinical Site
San Juan, PR, Puerto Rico
Countries
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References
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Farber RH, Angelov A, Kim K, Carmack T, Thai-Cuarto D, Roberts E. Clinical development of valbenazine for tics associated with Tourette syndrome. Expert Rev Neurother. 2021 Apr;21(4):393-404. doi: 10.1080/14737175.2021.1898948. Epub 2021 Apr 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NBI-98854-TS2004
Identifier Type: -
Identifier Source: org_study_id
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