Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate
Verified date | April 2015 |
Source | Klinikum Ludwigshafen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | September 2015 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Dept. of Neurology, Klinikum Ludwigshafen | Ludwigshafen |
Lead Sponsor | Collaborator |
---|---|
Klinikum Ludwigshafen |
Germany,
Wolf J, Safer A, Wöhrle 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. — View Citation
Wolf J, Safer A, Wöhrle 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 — View Citation
Wolf J, Wöhrle 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: 10.3109/21678421.2014.8877 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gastrostomy | gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration | an average of 3 years | No |
Primary | Death | death of participating ALS patients independent of the cause of death | an average of 3 years | No |
Secondary | Tracheostomy | tracheostomy in ALS patients following respiratory failure | an average of 3 years | No |
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