Effects of physostigimine and modafinil post brain injury
| ISRCTN | ISRCTN38764966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38764966 |
| Secondary identifying numbers | 02/212 |
- Submission date
- 08/09/2005
- Registration date
- 13/09/2005
- Last edited
- 18/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Menon
Scientific
Scientific
Divison of Anaesthesia
University of Cambridge
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Effects of physostigimine and modafinil post brain injury |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Patients who have suffered brain injury |
| Key exclusion criteria | Past history of psychiatric illness |
| Date of first enrolment | 02/01/2004 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Divison of Anaesthesia
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Addenbrookes NHS Trust Hospital + Cambridge University (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Claudia Rizzini
R&D Department
Addenbrookes Hospital
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/055vbxf86 |
|---|
Funders
Funder type
Hospital/treatment centre
Addenbrookes Hospital (UK) - Division of Anaesthesia
No information available
Medical Research Council (MRC) (UK) - Partially funded by MRC Grant No G9439390 ID 65883
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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
