Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr PJ Goadsby

ORCID ID

Contact details

Headache and Migraine Group
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
+44 020 7829 8749
peterg@ion.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263104924

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Migraine

Intervention

Clinical trial:
1. Intranasal ketamine
2. Midazolam

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient diary-based observations of progression of aura

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

30 Patients from Neurology.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Headache and Migraine Group
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University College London Hospitals NHS Trust (NHS R&D Support Funding)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23365053

Publication citations

  1. Results

    Afridi SK, Giffin NJ, Kaube H, Goadsby PJ, A randomized controlled trial of intranasal ketamine in migraine with prolonged aura., Neurology, 2013, 80, 7, 642-647, doi: 10.1212/WNL.0b013e3182824e66.

Additional files

Editorial Notes