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Trial record 21 of 677 for:    amyotrophic lateral sclerosis

Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01955369
Recruitment Status : Completed
First Posted : October 7, 2013
Results First Posted : April 22, 2015
Last Update Posted : May 19, 2016
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

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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

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

Information from the National Library of Medicine

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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)

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 identifier (NCT number): NCT01955369

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

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Joachim Wolf, Senior neurologist of the Dept. of Neurology, Klinikum Ludwigshafen 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:
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases