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Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,

NCT04873115 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-07-08

No results posted yet for this study

Summary

Double blind, placebo-controlled, randomised trial, multicentre in France with open-label tolerability phase.

The double-blind placebo-controlled study duration will be scheduled for 3 months with the final visit of the double-blind period at D84. After the D84 assessment, patients will be invited to continue into a 6-month openlabel study extension (OLSE) with ex-Sialanar® patients continuing the treatment and ex-placebo patients starting Sialanar®

Conditions

  • Sialorrhea
  • Neurodevelopmental Disorders

Interventions

OTHER

Placebo

Sialanar placebo

DRUG

Sialanar

Sialanar - a licensed glycopyrronium bromide product

OTHER

Oral Rehabilitation

Standard oral rehabilitation for provided drooling

Sponsors & Collaborators

  • Proveca Pharma Limited

    lead INDUSTRY

Principal Investigators

  • Nick Probert · Proveca Pharma Limited

  • Pierre Fayoux · CHU Lille

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
2021-05-10
Primary Completion
2022-12-10
Completion
2023-06-10

Countries

  • France

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 NCT04873115 on ClinicalTrials.gov