NCT01955369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 22, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.9 years

First QC Date

September 28, 2013

Results QC Date

April 6, 2015

Last Update Submit

April 13, 2016

Conditions

Amyotrophic Lateral Sclerosis

Keywords

incidencephenotypemortality

Outcome Measures

Primary Outcomes (1)

  • Death

    death of participating ALS patients independent of the cause of death

    an average of 3 years

Secondary Outcomes (1)

  • Tracheostomy

    an average of 3 years

Other Outcomes (1)

  • Gastrostomy

    an average of 3 years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Related Publications (4)

  • Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors Predicting Survival in ALS Patients--Data from a Population-Based Registry in Rhineland-Palatinate, Germany. Neuroepidemiology. 2015;44(3):149-55. doi: 10.1159/000381625. Epub 2015 Apr 21.

    PMID: 25895515BACKGROUND

  • Wolf J, Wohrle 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: 10.3109/21678421.2014.887733. Epub 2014 Feb 26.

    PMID: 24571628RESULT

  • Wolf J, Safer A, Wohrle 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.jns.2014.07.033. Epub 2014 Jul 19.

    PMID: 25086855RESULT

  • Wolf J, Safer A, Wohrle 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.

    PMID: 25280575RESULT

Related Links

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Joachim Wolf
Organization
Klinikum der Stadt Ludwigshafen
joachim.wolf@diakonissen.de
0049-621

Study Officials

  • Joachim Wolf, Dr

    Dept. Neurology, Klinikum Ludwigshafen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior neurologist of the Dept. of Neurology

Study Record Dates

First Submitted

September 28, 2013

First Posted

October 7, 2013

Study Start

October 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2015

Last Updated

May 19, 2016

Results First Posted

April 22, 2015

Record last verified: 2016-04

Locations

DE(1)