Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Tourette Syndrome

In brief

Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette Syndrome.

Key facts

Study ID

NCT02679079

Run by

Neurocrine Biosciences

People needed

98

Starts

2016-03-23

Expected to finish

2017-04-14

Last updated by the study team

2021-01-15

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

• Study site — Sun City, Arizona, United States
• Study site — Springdale, Arkansas, United States
• Study site — Long Beach, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — Upland, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Loxahatchee Groves, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Naperville, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Natick, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Bloomfield Hills, Michigan, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Nashua, New Hampshire, United States
• Study site — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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