Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/09/2005
Date assigned
13/09/2005
Last edited
18/07/2016
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

Prof David Menon

ORCID ID

Contact details

Divison of Anaesthesia
University of Cambridge
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02/212

Study information

Scientific title

Effects of physostigimine and modafinil post brain injury

Acronym

Study hypothesis

Investigation of the effects of physostigmine and modafinil on cognitive function post brain injury

Ethics approval

Cambridge Local Research Ethics Committee , 07/11/2002

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Severe head trauma, subarachnoid haemorrhage

Intervention

Patients are randomised to receive modafinil, physostigmine or placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cognitive changes noted on neuropsychology testing

Secondary outcome measures

Benefits noted on chronic therapy

Overall trial start date

02/01/2004

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have suffered brain injury

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Past history of psychiatric illness

Recruitment start date

02/01/2004

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Divison of Anaesthesia
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Addenbrookes NHS Trust Hospital + Cambridge University (UK)

Sponsor details

c/o Claudia Rizzini
R&D Department
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Addenbrookes Hospital (UK) - Division of Anaesthesia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (MRC) (UK) - Partially funded by MRC Grant No G9439390 ID 65883

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

18/07/2016: No publications found, verifying study status with principal investigator. 23/03/2010: This trial has been extended from 30/12/2007 to 31/12/2010