Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2008
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 Stephen Bourke

ORCID ID

Contact details

NHS Northern & Yorkshire Regional Office
Postgraduate Institute South Tyneside
10-12 Framlington Place
Newcastle upon Tyne
NE2 4AB
United Kingdom
+44 0191 284 311

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRCC804F res/1808/7002

Study information

Scientific title

Acronym

Study hypothesis

1. Early intervention with non-invasive ventilation will improve quality of life, survival and respiratory function in patients with motor neurone disease.
2. Domiciliary non-invasive ventilation in patients with motor neurone disease will not increase the stain experienced by the primary carer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nervous system diseases: motor neurone disease

Intervention

1. Early intervention with non-invasive ventilation
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quality of life
1. Generic instrument: Short Form 36
2. Specific instruments: Chronic Respiratory Disease Index, Sleep Apnoea Quality of Life Index, Epworth Sleepiness Scale

Secondary outcome measures

1. Survival
2. Impact on primary carer: Care Givers Strain Index
3. Hospital admissions
4. Respiratory function: Vital capacity, maximum static mouth pressures, sniff nasal inspiratory pressure

Overall trial start date

10/01/2000

Overall trial end date

10/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with motor neurone disease under 75 years of age and without other serious illnesses.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Added December 2008: 102

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/01/2000

Recruitment end date

10/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Northern & Yorkshire Regional Office
Newcastle upon Tyne
NE2 4AB
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16426990

Publication citations

  1. Results

    Bourke SC, Tomlinson M, Williams TL, Bullock RE, Shaw PJ, Gibson GJ, Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial., Lancet Neurol, 2006, 5, 2, 140-147, doi: 10.1016/S1474-4422(05)70326-4.

Additional files

Editorial Notes