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).
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02879578
Ages eligible for Study
6 Years to 64 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT02879578
Sun City, Arizona, United States
San Diego, California, United States
Loxahatchee, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Naperville, Illinois, United States
Lincoln, Nebraska, United States
Summit, New Jersey, United States
New York, New York, United States
Norristown, Pennsylvania, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Spokane, Washington, United States
View full eligibility
Tris trial is registered with FDA with number: NCT02879578. The sponsor of the trial is Neurocrine Biosciences and it is looking for 155 volunteers for the current phase.
Official trial title:
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