This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
vesicular monoamine transporter 2 (VMAT2) inhibitor
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Gulf Breeze, Florida, United States
Number of Participants With 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: Up to 16 Weeks
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Neurocrine Clinical Site
Hialeah, Florida, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Naperville, Illinois, United States
Neurocrine Clinical Site
Lincoln, Nebraska, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
San Juan, PR, Puerto Rico