Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Tourette Syndrome

In brief

This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.

Key facts

Study ID

NCT03325010

Run by

Neurocrine Biosciences

People needed

127

Starts

2017-10-05

Expected to finish

2018-11-16

Last updated by the study team

2021-06-28

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

Where it is running

• Neurocrine Clinical Site — Sun City, Arizona, United States
• Neurocrine Clinical Site — Rogers, Arkansas, United States
• Neurocrine Clinical Site — Anaheim, California, United States
• Neurocrine Clinical Site — San Diego, California, United States
• Neurocrine Clinical Site — Santa Clarita, California, United States
• Neurocrine Clinical Site — New Haven, Connecticut, United States
• Neurocrine Clinical Site — Hialeah, Florida, United States
• Neurocrine Clinical Site — Hialeah, Florida, United States
• Neurocrine Clinical Site — Hialeah, Florida, United States
• Neurocrine Clinical Site — Loxahatchee Groves, Florida, United States
• Neurocrine Clinical Site — Orange City, Florida, United States
• Neurocrine Clinical Site — Orlando, Florida, United States
• Neurocrine Clinical Site — Orlando, Florida, United States
• Neurocrine Clinical Site — Tampa, Florida, United States
• Neurocrine Clinical Site — Chicago, Illinois, 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 — Boston, Massachusetts, 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

Full record on ClinicalTrials.gov

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