Safety and Efficacy Study of NBI-98854 in Adults 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 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.

Key facts

Study ID

NCT02581865

Run by

Neurocrine Biosciences

People needed

124

Starts

2015-11-01

Expected to finish

2016-12-01

Last updated by the study team

2020-05-07

Who can join

Age: 18 and older, up to 64. 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
• Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, 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 tachy-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 known history of substance dependence, substance (drug) or alcohol abuse
• Have a significant risk of suicidal or violent behavior
• Are currently pregnant or breastfeeding
• 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 a blood loss ≥550 mL or donated blood within 30 days prior to screening

Where it is running

• Study site — Long Beach, California, United States
• Study site — National City, 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 — Gainesville, Florida, United States
• Study site — Hialeah, 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 — Boston, Massachusetts, United States
• Study site — Natick, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Nashua, New Hampshire, United States
• Study site — Summit, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Staten Island, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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