Effects of physostigimine and modafinil post brain injury
| ISRCTN | ISRCTN38764966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38764966 |
| Protocol serial number | 02/212 |
| Sponsor | Addenbrookes NHS Trust Hospital + Cambridge University (UK) |
| Funders | Addenbrookes Hospital (UK) - Division of Anaesthesia, Medical Research Council (MRC) (UK) - Partially funded by MRC Grant No G9439390 ID 65883 |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Cognitive changes noted on neuropsychology testing |
| Key secondary outcome measure(s) |
Benefits noted on chronic therapy |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Divison of Anaesthesia
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
