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

Completed · Phase 2

Conditions studied: Tourette Syndrome

In brief

Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS).

Key facts

Study ID

NCT02879578

Run by

Neurocrine Biosciences

People needed

155

Starts

2016-07-25

Expected to finish

2017-11-01

Last updated by the study team

2021-04-29

Who can join

Age: 6 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study
• 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
• 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
• Adolescent and adult subjects (12 to 64 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 who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study
• Be in good general health

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 a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age)
• 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 — San Diego, California, United States
• Study site — Loxahatchee Groves, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Naperville, Illinois, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Summit, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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