Condition category
Nervous System Diseases
Date applied
24/02/2005
Date assigned
13/04/2005
Last edited
16/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert J.O Davies

ORCID ID

Contact details

Consultant in Respiratory Medicine
Oxford Centre for Respiratory Medicine
Churchill Hospital
Headington
Oxford
OX3 7LJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C03.056

Study information

Scientific title

Acronym

Modafinil Study

Study hypothesis

Therefore we wish to examine brain activity and performance during hand/eye tracking manoeuvres, (as quantified by fMRI and our tracking tasks), in normal subjects before and after total sleep deprivation following treatment with Modafinil or placebo. We will compare whether the Modafinil has reversed the effects of the sleep deprivation, compared to placebo

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

Hospitals

Trial type

Other

Patient information sheet

Condition

N/A

Intervention

Please note that as of 16/09/09 the status of this trial has been changed to "Stopped" due to relocation of primary investigator (PI) and lack of funding.

Each subject will be scanned 3 times, the first as a baseline, after normal sleep, and then twice after sleep deprivation, following treatment with Modafinil or placebo, in random order. Within each scanning session the subject will perform a series of hand/eye tracking tests of varying difficulty in random order, and a global visual stimulation test. Following the scans objective sleepiness will be quantified from the OSLER test of subjective sleepiness and steering ability will be quantified from the Oxford Steering Simulator. Subjects will be pre-trained to stable performance on the tracking task prior to fMRI scanning.

Intervention type

Drug

Phase

Not Specified

Drug names

Modafinil

Primary outcome measures

The primary endpoint of the trial is the difference in activation of the occipital visual cortex area responsible motion detection (V5/MT) during global visual stimulation after Modafinil and placebo

Secondary outcome measures

Sleep latency (measured by the OSLER test), driving simulator performance and tracking error will be secondary endpoints

Overall trial start date

01/08/2004

Overall trial end date

30/06/2006

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

30 Healthy volunteers between the ages of 18-65

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Previous neurological disease

Recruitment start date

01/08/2004

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant in Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

University of Oxford (NDM)
Level 5
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Cephalon UK Ltd (UK) (ref: Davies2004/unrestricted grant)

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