Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea (ALS-TOX)

Civil Hospices of Lyon

Status and phase

Completed

Phase 2

Conditions

Sialorrhea

Amyotrophic Lateral Sclerosis

Treatments

Drug: Botox injection

Drug: Placebo injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01551940

2010.607/11

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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