Clinical Trials for Pediatric Chronic Sialorrhea | XEOMIN®

XEOMIN is the First and Only FDA-Approved Neuromodulator For Pediatric Patients With Chronic Sialorrhea

Pivotal Trial Design

  • Dose-response study of efficacy and safety of XEOMIN to treat children and adolescents (2–17 years) with chronic sialorrhea1

Coprimary endpoints1

  • For subjects aged 6–17 years
    • Change in uSFR from baseline to Week 4
    • Change in GICS from baseline to Week 4

Secondary endpoints1

  • For subjects aged 6–17 years
    • Change in uSFR from baseline to Week 8 and Week 12
    • GICS at Week 8 and Week 12
Clinical trial of XEOMIN® in Pediatric Patients with Chronic Sialorrhea Pinch to zoom

*Children aged 2–5 years were treated only with XEOMIN (open-label), and these patients were not included in calculation of the co-primary endpoints.

Reference

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2020.