Clinical trial NCT01551940: Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea
Official title: Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sialorrhea
Amyotrophic Lateral Sclerosis
Keywords: Sialorrhea
Amyotrophic lateral sclerosis
Botulinum toxin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Improvement of the functional embarrassment provoked by sialorrhea
timeFrame: 1 month after the injection
Secondary outcomes:
measure: Decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver
timeFrame: 1 month after the injection
measure: Improvement of the value of the hypersalivation item in ALSFRS-R scale
timeFrame: 1 month after the injection
measure: Decrease of the score of severity and frequency of the drooling rating scale
timeFrame: 1 month after the injection
measure: Decrease of the cotton roll weight
timeFrame: 1 month after the injection
measure: Decrease of the number of paper handkerchiefs used
timeFrame: 1 month after the injection
measure: Modification of the speech evaluation
timeFrame: 1 month after the injection
measure: Improvement of the quality of life
timeFrame: 1 month after the injection
measure: Description of patient cohort after the first injection
timeFrame: 6 months after the injection
Other outcomes:
Locations:
city: Angers cedex 9
country: France
facility: Département de Neurologie, Hôpital de l'Hôtel-Dieu, CHU d'Angers
city: Bron
country: France
facility: Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
city: Caen cedex 9
country: France
facility: Service de Neurologie Vastel, Hôpital Côte de Nacre, CHU de Caen
city: Clermont-Ferrand cedex 1
country: France
facility: Service de Neurologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand
city: Lille
country: France
facility: Centre SLA, Service de Neurologie A et pathologies du mouvement, Hôpital Roger Salengro, CHU de Lille
city: Limoges
country: France
facility: Service de Neurologie, Hôpital Dupuytren, CHU de Limoges
city: Marseille cedex 5
country: France
facility: Service de Neurologie, Hôpital de la Timone, CHU de Marseille
city: Nancy
country: France
facility: Service de Neurologie, Hôpital Central, CHU de Nancy
city: Nice cedex 3
country: France
facility: Centre de Référence maladies Neuromusculaires, Service de Médecine Physique et Réadaptation, Hôpital de l'Archet 1, CHU de Nice
city: Paris cedex 13
country: France
facility: Fédération des Maladies du Système Nerveux, Groupement Hospitalier Pitié Salpêtrière, AP-HP
city: Saint-Etienne cedex 2
country: France
facility: Service de Neurologie, CHU de Saint-Etienne
city: Strasbourg
country: France
facility: Département de Neurologie, Hôpital de Hautepierre, CHRU de Strasbourg
city: Toulouse
country: France
facility: Service d'Explorations Fonctionelles Neuro-Musculaires, Hôpital Rangueil, CHU de Toulouse
Study officials:
affiliation: Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
name: Christophe VIAL, MD
role: PRINCIPAL_INVESTIGATOR
References: