Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea

Phase 2CompletedNCT01551940

Hospices Civils de Lyon18 enrolled

Overview

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.

The patient will benefit from an ultrasound guided injection of botulinum toxin A (Botox®) or placebo (NaCl 0.9 %) and will be followed up in consultation at 4, 12, 16 (if reinjection) and 24 weeks. He will be contacted by telephone in 2 and in 8 weeks (percentage of decrease of functional embarrassment, percentage of decrease of salivary secretion rate). He can be able to benefit in the open label phase of a botulinum toxin type A injection at the 12-week follow up if he estimates that first injection was not effective or if the efficiency of the first injection began to become blurred. After the 6 months of the study, the patient will benefit again from the usual follow-up as advised by the French consensus conference in November, 2005.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Sialorrhea Amyotrophic Lateral Sclerosis

Interventions

Botox injectionDRUG

Local ultrasound-guided bilateral injection of botulinum toxin type A in parotid (35 UI/gland) and submandibular (15 UI/gland) glands.

Placebo injectionDRUG

A local ultrasound-guided bilateral injection of placebo (NaCl 0.9 %) in parotid (0.7 ml/gland) and submandibular (0.3 ml/gland) glands.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Département de Neurologie, Hôpital de l'Hôtel-Dieu, CHU d'Angers

Angers, France

Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

Bron, France

Outcomes

Primary Outcomes

Improvement of the functional embarrassment provoked by sialorrhea

Demonstrate after the injection of botulinum toxin type A an improvement of at least 25 % of the functional embarrassment provoked by sialorrhea in the ALS patient, evaluated with a horizontal visual analogue scale (VAS).