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Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS) (EpidALS)

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ClinicalTrials.gov Identifier: NCT03366506
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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Brief Summary:

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

  1. Differences between ethnic subgroups
  2. Differences between immigrant and native-born populations
  3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

Condition or disease Intervention/treatment
ALS Other: Observation

Detailed Description:

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

  1. Differences between ethnic subgroups
  2. Differences between immigrant and native-born populations
  3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

The clinical features will include pattern of onset, details of full clinical exam ( including ALSFRS-R score, power, reflexes, and other signs of upper or lower-motor neuron dysfunction.

Correlations between different clinical parameters themselves will be made, as well as correlation between clinical parameters and other epidemiological factors.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : March 9, 2009
Estimated Primary Completion Date : March 2049
Estimated Study Completion Date : January 2050

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ALS patients

ALS patients ( suspected, possible, probable or definite per El-Escorial criteria).

Observation

 Other: Observation


Outcome Measures
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Primary Outcome Measures :
  1. Progression rate [ Time Frame: up to 10 years ]
    Progression of ALSFRS-R score over time


Secondary Outcome Measures :
  1. Appearance of clinical features of UMN or LMN dysfunction [ Time Frame: 10 years ]
    Appearance of clinical features of UMN or LMN dysfunction over time


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Population referred to ALS clinic with suspected, possible, probable ,definite ALS
Criteria

Inclusion Criteria:

- Suspected, possible, probable ,definite ALS

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366506


Contacts
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Contact: Marc Gotkine, MBBS +972507874692 marc@gotkine.com

Locations
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Israel
Hadassah Medical Organisation Recruiting
Jerusalem, Israel, 91120
Contact: Marc Gotkine, MBBS    +972507874692    marc@gotkine.com   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Marc Gotkine, MBBS Hadassah Medical Organization
More Information
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Additional Information:

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03366506    
Other Study ID Numbers: 0633-08-HMO-CTIL
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Via specific collaboration agreements.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases