Clinical Trial: Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)

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 Summary: 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.
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: Improvement of the functional embarrassment provoked by sialorrhea [ Time Frame: 1 month after the injection ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver [ Time Frame: 1 month after the injection ]
    Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver by a horizontal visual analogue scale.
  • Improvement of the value of the hypersalivation item in ALSFRS-R scale [ Time Frame: 1 month after the injection ]
    Demonstrate, one month after the injection of botulinum toxin type A, an improvement of the value of the hypersalivation item in ALSFRS-R scale.
  • Decrease of the score of severity and frequency of the drooling rating scale [ Time Frame: 1 month after the injection ]
    Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the score of severity and frequency of the drooling rating scale
  • Decrease of the cotton roll weight [ Time Frame: 1 month after the injection ]

    Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the cotton roll weight.

    Cotton rolls weight: production and quantity of saliva are verified by placing dental cotton rolls during 3 minutes in the mouth of the patient and by comparing the weight of rolls dry and soaked with saliva.

  • Decrease of the number of paper handkerchiefs used [ Time Frame: 1 month after the injection ]
    Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the number of paper handkerchiefs used. We ask the patient to count the number of handkerchiefs used a day.
  • Modification of the speech evaluation [ Time Frame: 1 month after the injection ]
    Demonstrate, one month after the injection of botulinum toxin typeA, a modification of the speech evaluation (evaluation realized by speech evaluator)
  • Improvement of the quality of life [ Time Frame: 1 month after the injection ]
    Demonstrate, one month after the injection of botulinum toxin type A, an improvement of the quality of life. Scale to estimate quality of life (ALSAQ-40), usually used with the patients affected by ALS
  • Description of patient cohort after the first injection [ Time Frame: 6 months after the injection ]
    Describe cohort after the first injection: evolution of scores for every patient among Day0 and Month1, delay of appearance of the efficiency, the duration of effect of the treatment, the side effects, the modification of the consistency of the saliva and the possible necessity for re-injecting the patient at 3 months of follow-up.


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: March 9, 2012
Date Started: February 2012
Date Completion:
Last Updated: August 13, 2015
Last Verified: August 2015