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Trial record 21 of 677 for:    amyotrophic lateral sclerosis

Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

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ClinicalTrials.gov Identifier: NCT01955369
Recruitment Status : Completed
First Posted : October 7, 2013
Results First Posted : April 22, 2015
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Joachim Wolf, Klinikum Ludwigshafen

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Amyotrophic Lateral Sclerosis
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amyotrophic Lateral Sclerosis Patients
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 200
Completed 200
Not Completed 0
Arm/Group Title Amyotrophic Lateral Sclerosis Patients
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 200 participants
65.8
(23 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
94
  47.0%
Male
106
  53.0%
1.Primary Outcome
Title Death
Hide Description death of participating ALS patients independent of the cause of death
Time Frame an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amyotrophic Lateral Sclerosis Patients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 200
Measure Type: Number
Unit of Measure: participants
134
2.Secondary Outcome
Title Tracheostomy
Hide Description tracheostomy in ALS patients following respiratory failure
Time Frame an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amyotrophic Lateral Sclerosis Patients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 200
Measure Type: Number
Unit of Measure: participants
10
3.Other Pre-specified Outcome
Title Gastrostomy
Hide Description gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration
Time Frame an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amyotrophic Lateral Sclerosis Patients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 200
Measure Type: Number
Unit of Measure: participants
49
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amyotrophic Lateral Sclerosis Patients
Hide Arm/Group Description 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.
All-Cause Mortality
Amyotrophic Lateral Sclerosis Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amyotrophic Lateral Sclerosis Patients
Affected / at Risk (%)
Total   0/200 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amyotrophic Lateral Sclerosis Patients
Affected / at Risk (%)
Total   0/200 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Joachim Wolf
Organization: Klinikum der Stadt Ludwigshafen
Phone: 0049-621 ext 4200
EMail: joachim.wolf@diakonissen.de
Layout table for additonal information
Responsible Party: Joachim Wolf, Klinikum Ludwigshafen
ClinicalTrials.gov Identifier: NCT01955369     History of Changes
Other Study ID Numbers: 837.253.09
First Submitted: September 28, 2013
First Posted: October 7, 2013
Results First Submitted: April 6, 2015
Results First Posted: April 22, 2015
Last Update Posted: May 19, 2016