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

Headache and Migraine Group
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Phone +44 020 7829 8749
Email peterg@ion.ucl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesA 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) studiedMigraine
InterventionClinical trial:
1. Intranasal ketamine
2. Midazolam
Intervention typeOther
Primary outcome measurePatient diary-based observations of progression of aura
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2001
Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteria30 Patients from Neurology.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2001
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Headache and Migraine Group
London
WC1N 3BG
United Kingdom

Sponsor information

Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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