drugset / Trial / NCT01551940

Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea

NCT01551940 ↗

Phase 2 Completed 18 enrolled Hospices Civils de Lyon
RandomizedParallel-groupTriple-blindTreatment

Summary

Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.

Timeline

Start
2012-02
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu Other