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

NCT05097079 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

Summary

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

Conditions

  • Sialorrhea

Interventions

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)

Sponsors & Collaborators

  • Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC

    lead INDUSTRY

Principal Investigators

  • Jonathan Rubin, MD · Supernus Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-05-31
Completion
2023-05-31
FDA Drug
Yes

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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 NCT05097079 on ClinicalTrials.gov