Trial Outcomes & Findings for Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate (NCT NCT01955369)

NCT ID: NCT01955369

Last Updated: 2016-05-19

Results Overview

death of participating ALS patients independent of the cause of death

• Recruitment status: COMPLETED
• Target enrollment: 200 participants
• Primary outcome timeframe: an average of 3 years
• Results posted on: 2016-05-19

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	200
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

Baseline characteristics by cohort

Measure	Amyotrophic Lateral Sclerosis Patients n=200 Participants 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.
Age, Continuous	65.8 years n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants

PRIMARY outcome

Timeframe: an average of 3 years

death of participating ALS patients independent of the cause of death

Outcome measures

Measure	Amyotrophic Lateral Sclerosis Patients n=200 Participants 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.
Death	134 participants

SECONDARY outcome

Timeframe: an average of 3 years

tracheostomy in ALS patients following respiratory failure

Outcome measures

Measure	Amyotrophic Lateral Sclerosis Patients n=200 Participants 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.
Tracheostomy	10 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: an average of 3 years

gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration

Outcome measures

Measure	Amyotrophic Lateral Sclerosis Patients n=200 Participants 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.
Gastrostomy	49 participants

Adverse Events

Amyotrophic Lateral Sclerosis Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joachim Wolf

Klinikum der Stadt Ludwigshafen

Phone: 0049-621

Email: joachim.wolf@diakonissen.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place