Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

Completed · Phase 2

Conditions studied: Tourette Syndrome

In brief

This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.

Key facts

Study ID

NCT03444038

Run by

Neurocrine Biosciences

People needed

85

Starts

2018-02-08

Expected to finish

2019-07-12

Last updated by the study team

2022-02-23

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have participated in and completed Study NBI-98854-TS2003
• Have a clinical diagnosis of Tourette Syndrome (TS)
• 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 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
• 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 vesicular monoamine transporter 2 (VMAT2) inhibitors
• Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline
• Have a known history of substance (drug) dependence, or substance or alcohol abuse
• Have a significant risk of suicidal or violent behavior
• 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 — 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

Full record on ClinicalTrials.gov

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