Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Tourette Syndrome

In brief

This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.

Key facts

Study ID

NCT03530293

Run by

Neurocrine Biosciences

People needed

81

Starts

2018-04-17

Expected to finish

2019-07-16

Last updated by the study team

2022-05-17

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a clinical diagnosis of Tourette Syndrome (TS)
• Have at least moderate tic severity
• Have TS symptoms that impair school, occupational, and/or social function
• 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
• Be in good general health
• 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
• 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

You may not qualify if…

• Have an active, clinically significant unstable medical condition within 1 month prior to screening
• Have a known history of long QT syndrome or cardiac arrhythmia
• Have a known history of neuroleptic malignant syndrome
• Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
• Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
• Have a blood loss ≥250 mL or donated blood within 30 days prior to screening
• Have a known history of substance dependence, substance (drug) or alcohol abuse
• Have a significant risk of suicidal or violent behavior
• Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
• 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 previously participated in an NBI-98854 clinical study, except for NBI-98854-1403 or NBI-98854-1501.
• Have HIV, hepatitis B, or hepatitis C

Where it is running

• 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

Full record on ClinicalTrials.gov

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