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 |
| Protocol serial number | N0263104924 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (NHS R&D Support Funding) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Patient diary-based observations of progression of aura |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Headache and Migraine Group
London
WC1N 3BG
United Kingdom
WC1N 3BG
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? |
|---|---|---|---|---|---|
| Results article | results | 12/02/2013 | Yes | No |
