Comparative study of the efficacy and safety of intranasal ketamine and midazolam for the acute treatment of migraine with prolonged aura
| ISRCTN | ISRCTN18446134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18446134 |
| Secondary identifying numbers | N0263104924 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 06/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr PJ Goadsby
Scientific
Scientific
Headache and Migraine Group
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
| Phone | +44 020 7829 8749 |
|---|---|
| peterg@ion.ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | A comparative study of the efficacy and safety of intranasal ketamine and midazolam for the acute treatment of migraine with prolonged aura and familial hemiplegic migraine. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Migraine |
| Intervention | Clinical trial: 1. Intranasal ketamine 2. Midazolam |
| Intervention type | Other |
| Primary outcome measure | Patient diary-based observations of progression of aura |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2001 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 |
| Key inclusion criteria | 30 Patients from Neurology. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headache and Migraine Group
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust (NHS R&D Support Funding)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/02/2013 | Yes | No |
