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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 August 2015 |
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Main ID: |
NCT01551940 |
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Date of registration:
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09/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea
ALS-TOX |
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Scientific title:
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Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01551940 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Christophe VIAL, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Sialorrhea
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Intervention(s)
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Drug: Botox injection
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Drug: Placebo injection
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Primary Outcome(s)
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Improvement of the functional embarrassment provoked by sialorrhea
[Time Frame: 1 month after the injection]
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Secondary Outcome(s)
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Description of patient cohort after the first injection
[Time Frame: 6 months after the injection]
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Decrease of the score of severity and frequency of the drooling rating scale
[Time Frame: 1 month after the injection]
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Improvement of the value of the hypersalivation item in ALSFRS-R scale
[Time Frame: 1 month after the injection]
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Modification of the speech evaluation
[Time Frame: 1 month after the injection]
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Decrease of the cotton roll weight
[Time Frame: 1 month after the injection]
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Decrease of the number of paper handkerchiefs used
[Time Frame: 1 month after the injection]
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Decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver
[Time Frame: 1 month after the injection]
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Improvement of the quality of life
[Time Frame: 1 month after the injection]
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Secondary ID(s)
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2010.607/11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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