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

NCT03444038 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-02-23

Study results available
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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

DRUG

Valbenazine

vesicular monoamine transporter 2 (VMAT2) inhibitor

Sponsors & Collaborators

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Clinical Development Lead · Neurocrine Biosciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2019-07-12
Completion
2019-07-12
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03444038 on ClinicalTrials.gov