NCT00337402

Brief Summary

Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Typical duration 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

January 1, 2002

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
Last Updated

November 22, 2006

Status Verified

June 1, 2006

First QC Date

June 15, 2006

Last Update Submit

November 20, 2006

Conditions

Amyotrophic Lateral Sclerosis

Keywords

GastrostomyQuality of life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients \> 18 years-old
  • ALS certain or probable
  • vital capacity (respiratory) \> 70 %
  • under riluzole

You may not qualify if:

  • ALS in family
  • other conditions affected survival and QoL
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

Location

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

  • Pierre Clavelou

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 16, 2006

Study Start

January 1, 2002

Study Completion

June 1, 2005

Last Updated

November 22, 2006

Record last verified: 2006-06

Locations

FR(1)