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
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
-
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.