Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea
ALS-TOX
Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)
1 other identifier
interventional
18
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2012
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 9, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedAugust 14, 2015
August 1, 2015
2.1 years
March 9, 2012
August 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
1 month after the injection
Secondary Outcomes (8)
Decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver
1 month after the injection
Improvement of the value of the hypersalivation item in ALSFRS-R scale
1 month after the injection
Decrease of the score of severity and frequency of the drooling rating scale
1 month after the injection
Decrease of the cotton roll weight
1 month after the injection
Decrease of the number of paper handkerchiefs used
1 month after the injection
- +3 more secondary outcomes
Study Arms (2)
Botox
EXPERIMENTALBotox injection : 100 UI of botulinum toxin type A (Botox®) diluted in 2.2 ml of NaCl 0.9 %
Placebo
PLACEBO COMPARATORPlacebo injection : NaCl 0.9 %
Interventions
Local ultrasound-guided bilateral injection of botulinum toxin type A in parotid (35 UI/gland) and submandibular (15 UI/gland) glands.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Evolving disease associated with predictable survival \< 1 month
- Patient having previously received an injection of botulinum toxin in the salivary glands
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Département de Neurologie, Hôpital de l'Hôtel-Dieu, CHU d'Angers
Angers, 49933, France
Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Bron, 69677, France
Service de Neurologie Vastel, Hôpital Côte de Nacre, CHU de Caen
Caen, 14033, France
Service de Neurologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
Centre SLA, Service de Neurologie A et pathologies du mouvement, Hôpital Roger Salengro, CHU de Lille
Lille, 59037, France
Service de Neurologie, Hôpital Dupuytren, CHU de Limoges
Limoges, 87042, France
Service de Neurologie, Hôpital de la Timone, CHU de Marseille
Marseille, 13385, France
Service de Neurologie, Hôpital Central, CHU de Nancy
Nancy, 54035, France
Centre de Référence maladies Neuromusculaires, Service de Médecine Physique et Réadaptation, Hôpital de l'Archet 1, CHU de Nice
Nice, 06202, France
Fédération des Maladies du Système Nerveux, Groupement Hospitalier Pitié Salpêtrière, AP-HP
Paris, 75651, France
Service de Neurologie, CHU de Saint-Etienne
Saint-Etienne, 42055, France
Département de Neurologie, Hôpital de Hautepierre, CHRU de Strasbourg
Strasbourg, 67091, France
Service d'Explorations Fonctionelles Neuro-Musculaires, Hôpital Rangueil, CHU de Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe VIAL, MD
Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2012
First Posted
March 13, 2012
Study Start
February 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
August 14, 2015
Record last verified: 2015-08