Condition category
Nervous System Diseases
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
05/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M M van der Graaff

ORCID ID

Contact details

Academic Medical Centre
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3647
m.m.vandergraaff@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Early Percutaneous Endoscopic Gastrostomy (PEG) placement in Amyotrophic Lateral Sclerosis (ALS) patients with dysphagia is associated with longer survival, better nutritional and functional status, and better quality of life.

Ethics approval

Approval received from the Medical Ethical Committee of Academic Medical Centre on the 19th March 2003 (ref: MEC 02/184).

Study design

Randomised, active-controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Amyotrophic Lateral Sclerosis (ALS), Dysphagia

Intervention

Arm one: patients receive a PEG within one month after inclusion
Arm two: patients wait untill either VC falls below 55%, or Hillel score is four or five, or any other moment that they decide for themselves to have a PEG placed

Effects of these two strategies on survival, nutritional and functional status, and quality of life are investigated. Follow-up is in 15 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Survival.

Secondary outcome measures

1. Vital capacity
2. Body Mass Index (BMI)
3. Triceps skinfold
4. ALS Functional Rating Scale (ALSFRS)
5. Visual Analogue Scale for Quality of Life (VAS QoL)
6. Short Form health survey (SF 36)

Overall trial start date

04/08/2004

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with possible, probable, probable laboratory supported, or definite ALS
2. Dysphagia Hillel score seven or eight (ALS Severity Scale [ALSSS] dysphagia subscale)
3. Vital Capacity (VC) more than 65%
4. Aged more than 18 years and less than 85 years
5. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Contra-indications for PEG

Recruitment start date

04/08/2004

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/#http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

Prinses Beatrix Fonds (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes