ALSEpidALSNCT03366506
Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)
An observational study of ALS, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- ALS
- What is being tested?
- Observation
- How many people
- 2,000 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Mar 2009to Jan 2050
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 120 years
- All sexes
- Child, Adult, Older adult
Study population: Population referred to ALS clinic with suspected, possible, probable ,definite ALS
Who may be able to join
- Suspected, possible, probable ,definite ALS
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organisation
Jerusalem, 91120
Marc Gotkine, MBBS, +972507874692, marc@gotkine.com
About this study
Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-
- Differences between ethnic subgroups
- Differences between immigrant and native-born populations
- 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.
Read the detailed description
Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-
- Differences between ethnic subgroups
- Differences between immigrant and native-born populations
- 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.
- Conditions
- ALS
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | ALS patients ( suspected, possible, probable or definite per El-Escorial criteria).
Observation Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression rate
Progression of ALSFRS-R score over time
Measured: up to 10 years
Secondary outcomes (1)
Appearance of clinical features of UMN or LMN dysfunction
Appearance of clinical features of UMN or LMN dysfunction over time
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start9 Mar 2009
- Primary completionMar 2049 (estimated)
- Study completionJan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Gotkine, MBBS, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366506
- Sponsor's protocol ID
- 0633-08-HMO-CTIL
- Acronym
- EpidALS
- Status last verified
- Feb 2021
- First submitted
- 4 Dec 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Via specific collaboration agreements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT03366506
- Acronym / sponsor ID
- EpidALS / 0633-08-HMO-CTIL
- Conditions
- ALS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 9 Mar 2009 (actual)
- Primary completion
- Mar 2049 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-
- Differences between ethnic subgroups
- Differences between immigrant and native-born populations
- 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.
Detailed description
Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-
- Differences between ethnic subgroups
- Differences between immigrant and native-born populations
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | Other: ObservationALS patients ( suspected, possible, probable or definite per El-Escorial criteria). Observation |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Population referred to ALS clinic with suspected, possible, probable ,definite ALS
Key inclusion criteria (1 listed)
- Suspected, possible, probable ,definite ALS
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation | Other | ALS patients |
Primary outcome
Progression rate
Time frame: up to 10 years
Progression of ALSFRS-R score over time
1 secondary outcome
Appearance of clinical features of UMN or LMN dysfunction
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided. Via specific collaboration agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Gotkine, MBBS principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Gotkine, MBBS (+972507874692, marc@gotkine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression rate (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.