Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Cambridge Local Research Ethics Committee , 07/11/2002
Study design
Randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Primary outcome measure
Cognitive changes noted on neuropsychology testing
Secondary outcome measures
Benefits noted on chronic therapy
Overall study start date
02/01/2004
Overall study end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who have suffered brain injury
Participant type(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|