Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

April 13, 2016 updated by: Joachim Wolf, Klinikum Ludwigshafen
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ludwigshafen, Germany, 67063
        • Dept. of Neurology, Klinikum Ludwigshafen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

residents of the state of Rhineland-Palatinate, Germany (4 million inhabitants)

Description

Inclusion Criteria:

  • diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria
  • minimum of 18 years
  • minimum of 6 months of residency in Rhinelnad-Palatinate

Exclusion Criteria:

  • patients below 18 years
  • ALS patients outside Rhineland-Palatinate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: an average of 3 years
death of participating ALS patients independent of the cause of death
an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracheostomy
Time Frame: an average of 3 years
tracheostomy in ALS patients following respiratory failure
an average of 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrostomy
Time Frame: an average of 3 years
gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration
an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Ludwigshafen

Investigators

  • Principal Investigator: Joachim Wolf, Dr, Dept. Neurology, Klinikum Ludwigshafen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 28, 2013

First Submitted That Met QC Criteria

September 28, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 837.253.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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