NCT03536962

Brief Summary

Analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored through a Cohort study at Geneva University Hospitals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 25, 2018

Status Verified

April 1, 2018

Enrollment Period

4.3 years

First QC Date

January 14, 2018

Last Update Submit

May 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Longitudinal change of the revised Amyotrophic Lateral Sclerosis Functional rating scale in Amyotrophic Lateral Sclerosis patients

    Clinical evolution of Amyotrophic Lateral Sclerosis patients will be measured by the revised Amyotrophic Lateral Sclerosis Functional rating scale. This scale includes 12 questions covering 4 distinct domains: fine motor function, gross motor function, respiratory function and bulbar symptoms. Lower scores indicate higher disability.This score will be assessed every three months

    2012-2016

Secondary Outcomes (4)

  • Correlation of walking speed measured by Timed Up and Go test and the Amyotrophic Lateral Sclerosis Functional rating scale (ALSFRS-R)

    2012-2016

  • Longitudinal evolution of pulmonary function in ALS patients

    2012-2016

  • Evolution of body mass composition measured by the Body Mass Index in ALS patients

    2012-2016

  • Longitudinal evolution of inspiratory muscle strength in ALS patients

    2012-2016

Interventions

no intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients living in the Geneva area suffering from Amyotrophic Lateral Sclerosis or related disorders

You may qualify if:

  • Amyotrophic Lateral Sclerosis fulfilling the El Escorial criteria (definite, probable, possible), primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

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

Study Officials

  • Jean-Paul Janssens, MD

    University Hospital, Geneva

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief resident

Study Record Dates

First Submitted

January 14, 2018

First Posted

May 25, 2018

Study Start

June 1, 2012

Primary Completion

September 1, 2016

Study Completion

October 1, 2018

Last Updated

May 25, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations