Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Age > 18 years

• Obtaining of a written consent after information

• Diagnosis of probable or certain ALS according to the El Escorial criteria of the World Federation and Neurology Committee on Neuromuscular Diseases

• Patient having a follow-up in an ALS center

• Sialorrhea with VAS functional embarrassment > or equal at 50/100.

• Patient beneficiary of Social Security regime

Exclusion Criteria:

• Evolving disease associated with predictable survival < 1 month

• Patient having previously received an injection of botulinum toxin in the salivary glands

• Patient taking the other medical treatments for sialorrhea in the 7 days before the inclusion in the study (scopoderm, trihexyph'nidyle, atropine, ipatropium, amitriptyline, clomipramine, oxybutinine, diphenhydramine, beta-blockers)

• Patient having benefited from radiotherapy or from surgery on the salivary glands

• Behavioral problems, dementia or other psychiatric problems

• Myasthenia

• Known Pregnancy or absence of contraception recognized as effective, breast feeding