Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01551940
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 13, 2012
Last Update Posted Date August 14, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2012)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01551940 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2012)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sialorrhea
  • Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Drug: Botox injection
    Local ultrasound-guided bilateral injection of botulinum toxin type A in parotid (35 UI/gland) and submandibular (15 UI/gland) glands.
  • Drug: Placebo injection
    A local ultrasound-guided bilateral injection of placebo (NaCl 0.9 %) in parotid (0.7 ml/gland) and submandibular (0.3 ml/gland) glands.
Study Arms  ICMJE
  • Experimental: Botox
    Botox injection : 100 UI of botulinum toxin type A (Botox®) diluted in 2.2 ml of NaCl 0.9 %
    Intervention: Drug: Botox injection
  • Placebo Comparator: Placebo
    Placebo injection : NaCl 0.9 %
    Intervention: Drug: Placebo injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2012)
90
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01551940
Other Study ID Numbers  ICMJE 2010.607/11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe VIAL, MD Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP