Amyotrophic Lateral SclerosisNCT01955369
Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate
An observational study of Amyotrophic Lateral Sclerosis, run by Klinikum Ludwigshafen at 1 site in Germany.
Trial summary
There is a lack of prospective and population-based epidemiological data on amyotrophic lateral sclerosis in Germany so far. The purpose of this registry is to investigate the incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German state of about 4 million inhabitants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Sep 2015
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: residents of the state of Rhineland-Palatinate, Germany (4 million inhabitants)
Who may be able to join
- diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria
- minimum of 18 years
- minimum of 6 months of residency in Rhinelnad-Palatinate
Who cannot join
- patients below 18 years
- ALS patients outside Rhineland-Palatinate
Trial locations and contacts
1 site in 1 country.
About this study
There is a lack of prospective and population-based epidemiological data on amyotrophic lateral sclerosis in Germany so far. The purpose of this registry is to investigate the incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German state of about 4 million inhabitants.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- incidence, phenotype, mortality
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic lateral sclerosis patients | Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
death of participating ALS patients independent of the cause of death
Measured: an average of 3 years
Secondary outcomes (1)
Tracheostomy
tracheostomy in ALS patients following respiratory failure
Measured: an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2009
- Primary completionSep 2012
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Klinikum Ludwigshafen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Wolf, Klinikum Ludwigshafen
- Investigators
- Joachim Wolf, Dr, Principal investigator, Dept. Neurology, Klinikum Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955369
- Sponsor's protocol ID
- 837.253.09
- Status last verified
- Apr 2016
- First submitted
- 28 Sep 2013
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors Predicting Survival in ALS Patients--Data from a Population-Based Registry in Rhineland-Palatinate, Germany. Neuroepidemiology. 2015;44(3):149-55. doi: 10.1159/000381625. Epub 2015 Apr 21.
PubMed 25895515Wolf J, Wohrle JC, Palm F, Nix WA, Maschke M, Safer A, Becher H, Grau AJ. Incidence of amyotrophic lateral sclerosis in Rhineland-Palatinate, Germany. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):269-74. doi: 10.3109/21678421.2014.887733. Epub 2014 Feb 26.
PubMed 24571628Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Variability and prognostic relevance of different phenotypes in amyotrophic lateral sclerosis - data from a population-based registry. J Neurol Sci. 2014 Oct 15;345(1-2):164-7. doi: 10.1016/j.jns.2014.07.033. Epub 2014 Jul 19.
PubMed 25086855Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors predicting one-year mortality in amyotrophic lateral sclerosis patients--data from a population-based registry. BMC Neurol. 2014 Oct 4;14:197. doi: 10.1186/s12883-014-0197-9.
PubMed 25280575Wolf J, Safer A, Stefenelli U, Woehrle JC, Maschke M, Nix WA, Grau AJ. Long-term survival in amyotrophic lateral sclerosis - data from a population-based registry in Rhineland-Palatinate, Germany. BMC Neurol. 2026 Aug 27;26(1):546. doi: 10.1186/s12883-026-05325-2.
PubMed 42661170
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate
- ClinicalTrials.gov ID
- NCT01955369
- Acronym / sponsor ID
- 837.253.09
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- incidence, phenotype, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Klinikum LudwigshafenUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Posted 22 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a lack of prospective and population-based epidemiological data on amyotrophic lateral sclerosis in Germany so far. The purpose of this registry is to investigate the incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German state of about 4 million inhabitants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amyotrophic lateral sclerosis patients | – | –Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- residents of the state of Rhineland-Palatinate, Germany (4 million inhabitants)
Key inclusion criteria (3 listed)
- diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria
- minimum of 18 years
- minimum of 6 months of residency in Rhinelnad-Palatinate
Key exclusion criteria (2 listed)
- patients below 18 years
- ALS patients outside Rhineland-Palatinate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: an average of 3 years
death of participating ALS patients independent of the cause of death
1 secondary outcome
Tracheostomy
Time frame: an average of 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25895515Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors Predicting Survival in ALS Patients--Data from a Population-Based Registry in Rhineland-Palatinate, Germany. Neuroepidemiology. 2015;44(3):149-55. doi: 10.1159/000381625. Epub 2015 Apr 21.
- Results publication: PubMed 24571628Wolf J, Wohrle JC, Palm F, Nix WA, Maschke M, Safer A, Becher H, Grau AJ. Incidence of amyotrophic lateral sclerosis in Rhineland-Palatinate, Germany. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):269-74. doi: 10.3109/21678421.2014.887733. Epub 2014 Feb 26.
- Results publication: PubMed 25086855Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Variability and prognostic relevance of different phenotypes in amyotrophic lateral sclerosis - data from a population-based registry. J Neurol Sci. 2014 Oct 15;345(1-2):164-7. doi: 10.1016/j.jns.2014.07.033. Epub 2014 Jul 19.
- Results publication: PubMed 25280575Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors predicting one-year mortality in amyotrophic lateral sclerosis patients--data from a population-based registry. BMC Neurol. 2014 Oct 4;14:197. doi: 10.1186/s12883-014-0197-9.
- Derived from this study: PubMed 42661170Wolf J, Safer A, Stefenelli U, Woehrle JC, Maschke M, Nix WA, Grau AJ. Long-term survival in amyotrophic lateral sclerosis - data from a population-based registry in Rhineland-Palatinate, Germany. BMC Neurol. 2026 Aug 27;26(1):546. doi: 10.1186/s12883-026-05325-2.
- Amyotrophic lateral sclerosis registry Rhineland-PalatinateLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Joachim Wolf, Dr principal investigator
Dept. Neurology, Klinikum Ludwigshafen
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 Amyotrophic Lateral Sclerosis, run by Klinikum Ludwigshafen at 1 site in Germany.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 May 2016. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955369, which also lists 5 linked publications.
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 19 May 2016.