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NCT01955369 Clinical Trial

Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01955369
Other study ID # 837.253.09
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 28, 2013
Last updated April 21, 2015
Start date October 2009
Est. completion date September 2015

Study information
Verified date April 2015
Source Klinikum Ludwigshafen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility
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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Dept. of Neurology, Klinikum Ludwigshafen Ludwigshafen

Sponsors (1)
Lead Sponsor Collaborator
Klinikum Ludwigshafen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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

Outcome
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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Completed NCT01925196 - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
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Not yet recruiting NCT05860244 - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients Phase 2
Not yet recruiting NCT06450691 - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts N/A
Recruiting NCT02917681 - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
Recruiting NCT02874209 - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis N/A

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