NCT03444038

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

Open-Label Safety and Tolerability Study of Optimized Doses of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	Valbenazine	vesicular monoamine transporter 2 (VMAT2) inhibitor

Timeline

• Start date: 2018-02-08
• Primary completion: 2019-07-12
• Completion: 2019-07-12
• First posted: 2018-02-23
• Last updated: 2022-02-23
• Results posted: 2022-02-23

Locations

37 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study