NCT05097079

Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® for the Treatment of Chronic Sialorrhea in Pediatric Subjects

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of MYOBLOC for the treatment of chronic sialorrhea in pediatric subjects.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, single treatment study designed to assess the efficacy, safety, and tolerability of 2 dose levels of MYOBLOC vs placebo for the treatment of chronic sialorrhea in pediatric subjects ages 3 to \< 17 years. Eligible subjects will be randomized 1:1:1 to receive single treatment of the low dose of MYOBLOC (60 Units/kg), the high dose of MYOBLOC (100 Units/kg), or volume-matched placebo via intraglandular injection.

Conditions

• Sialorrhea

Interventions

Type	Name	Description
DRUG	MYOBLOC Low Dose	Subjects assigned to the MYOBLOC Low Dose treatment group will be administered MYOBLOC (60 units/kg; maximum 1800 units) as a single treatment via intraglandular injection (5.0 units/kit per submandibular gland \[maximum 150 units\] and 25.0 units/kg per parotid gland \[maximum 750 units\])
DRUG	MYOBLOC High Dose	Subjects assigned to the MYOBLOC High Dose treatment group will be administered MYOBLOC (100 units/kg; maximum 3000 units) as a single treatment via intraglandular injection (25.0 units/kit per submandibular gland \[maximum 300 units\] and 40.0 units/kg per parotid gland \[maximum 1200 units\])
DRUG	Placebo	Subjects assigned to the Placebo treatment group will be administered volume-matched placebo (1:1)

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2021-10-27
• Last updated: 2024-09-19

Regulatory

• FDA-regulated drug study