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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Unnamed facility
Sun City, Arizona, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Loxahatchee Groves, Florida, United States
Unnamed facility
Frequency of Treatment-emergent Adverse Events (TEAEs)
A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing.
Time frame: Baseline through Week 28
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St. Petersburg, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Naperville, Illinois, United States
Unnamed facility
Lincoln, Nebraska, United States
Unnamed facility
Summit, New Jersey, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Norristown, Pennsylvania, United States
...and 3 more locations