Amyotrophic Lateral Sclerosis
Conditions
Keywords
incidence, phenotype, mortality
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.
Interventions
None listed
Sponsors
Klinikum Ludwigshafen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | an average of 3 years | death of participating ALS patients independent of the cause of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tracheostomy | an average of 3 years | tracheostomy in ALS patients following respiratory failure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastrostomy | an average of 3 years | gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | Amyotrophic Lateral Sclerosis Patients |
|---|---|
| Age, Continuous | 65.8 years |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
Primary
Death
death of participating ALS patients independent of the cause of death
Time frame: an average of 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amyotrophic Lateral Sclerosis Patients | Death | 134 participants |
Secondary
Tracheostomy
tracheostomy in ALS patients following respiratory failure
Time frame: an average of 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amyotrophic Lateral Sclerosis Patients | Tracheostomy | 10 participants |
Other Pre-specified
Gastrostomy
gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration
Time frame: an average of 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amyotrophic Lateral Sclerosis Patients | Gastrostomy | 49 participants |