Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 05
Study information
Scientific title
Acronym
Study hypothesis
That clopidogrel is effective for the prophylaxis of migraine with or without the presence of a patent foramen ovale.
Ethics approval
Ethics approval received from Guy's Hospital Ethics Committee on the 17th December 2007 (ref: 07/H0804/139).
Study design
Randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Migraine
Intervention
1. Clopidogrel 75 mg orally once daily to be taken for three months
2. Placebo
The study has a one month run-in prior to treatment. After the three month treatment there is no further follow-up.
Intervention type
Drug
Phase
Not Specified
Drug names
Clopidogrel
Primary outcome measure
The number of headache-free days in one month (28 days). Migraine will be assessed using a headache diary kept for 28 days during run-in then again for the final 28 days of the three-month treatment period.
Secondary outcome measures
1. Frequency of attacks
2. Severity of attacks
3. Duration of attacks
Migraine will be assessed using a headache diary kept for 28 days during run-in then again for the final 28 days of the three-month treatment period. In addition the patients will have the 6-item Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) questionnaires at the start and end of the study.
Overall trial start date
01/05/2008
Overall trial end date
30/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age greater than 18 years, either sex
2. Migraine as defined by International Headache Criteria
3. More than two attacks in 28 days
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
286
Participant exclusion criteria
1. High risk features suggesting cerebral malignancy
2. Contra-indications to clopidogrel
3. Requirements for routine non-steroidal anti-inflammatory agent or aspirin other than for acute headache
4. Use of an investigational product within three months
5. Inability to understand English
6. Pregnancy or breast-feeding
7. Abnormal platelet or liver function
Recruitment start date
01/05/2008
Recruitment end date
30/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiothoracic Centre
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas NHS Trust (UK)
Sponsor details
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Dunhill Medical Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanofi-Aventis (UK)
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24836213
Publication citations
-
Results
Chambers JB, Seed PT, Ridsdale L, Clopidogrel as prophylactic treatment for migraine: A pilot randomised, controlled study., Cephalalgia, 2014, 34, 14, 1163-1168, doi: 10.1177/0333102414531156.