NCT03366506

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. 1.Differences between ethnic subgroups
  2. 2.Differences between immigrant and native-born populations
  3. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
288mo left

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Mar 2009Jan 2050

Study Start

First participant enrolled

March 9, 2009

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
31.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2049

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

40 years

First QC Date

December 4, 2017

Last Update Submit

February 9, 2021

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

  • Progression rate

    Progression of ALSFRS-R score over time

    up to 10 years

Secondary Outcomes (1)

  • Appearance of clinical features of UMN or LMN dysfunction

    10 years

Study Arms (1)

ALS patients

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

Other: Observation

Interventions

ObservationOTHER
ALS patients

Eligibility Criteria

Age12 Years - 120 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population referred to ALS clinic with suspected, possible, probable ,definite ALS

You may qualify if:

  • \- Suspected, possible, probable ,definite ALS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organisation

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Marc Gotkine, MBBS

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Gotkine, MBBS

CONTACT

+972507874692marc@gotkine.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 8, 2017

Study Start

March 9, 2009

Primary Completion (Estimated)

March 1, 2049

Study Completion (Estimated)

January 1, 2050

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

IL(1)