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Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

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ClinicalTrials.gov Identifier: NCT01955369
Recruitment Status : Completed
First Posted : October 7, 2013
Results First Posted : April 22, 2015
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Joachim Wolf, Klinikum Ludwigshafen

Brief 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.

Condition or disease
Amyotrophic Lateral Sclerosis

Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate
Study Start Date : October 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2015


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.



Primary Outcome Measures :
  1. Death [ Time Frame: an average of 3 years ]
    death of participating ALS patients independent of the cause of death


Secondary Outcome Measures :
  1. Tracheostomy [ Time Frame: an average of 3 years ]
    tracheostomy in ALS patients following respiratory failure


Other Outcome Measures:
  1. Gastrostomy [ Time Frame: an average of 3 years ]
    gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
residents of the state of Rhineland-Palatinate, Germany (4 million inhabitants)
Criteria

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

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): NCT01955369


Locations
Germany
Dept. of Neurology, Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063
Sponsors and Collaborators
Klinikum Ludwigshafen
Investigators
Principal Investigator: Joachim Wolf, Dr Dept. Neurology, Klinikum Ludwigshafen

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Joachim Wolf, Senior neurologist of the Dept. of Neurology, Klinikum Ludwigshafen
ClinicalTrials.gov Identifier: NCT01955369     History of Changes
Other Study ID Numbers: 837.253.09
First Posted: October 7, 2013    Key Record Dates
Results First Posted: April 22, 2015
Last Update Posted: May 19, 2016
Last Verified: April 2016

Keywords provided by Joachim Wolf, Klinikum Ludwigshafen:
incidence
phenotype
mortality

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases