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ISRCTN
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ISRCTN35114412
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ClinicalTrials.gov identifier
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Public title
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Clopidogrel as prophylactic treatment for migraine
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Scientific title
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Acronym
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N/A
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Serial number at source
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Version 05
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Study hypothesis
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That clopidogrel is effective for the prophylaxis of migraine with or without the presence of a patent foramen ovale.
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Ethics approval
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Ethics approval received from Guy's Hospital Ethics Committee on the 17th December 2007 (ref: 07/H0804/139).
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Study design
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Randomised placebo-controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Migraine
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Participants - inclusion criteria
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1. Age greater than 18 years, either sex
2. Migraine as defined by International Headache Criteria
3. More than two attacks in 28 days
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Participants - exclusion criteria
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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 Engish
6. Pregnancy or breast-feeding
7. Abnormal platelet or liver function
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Anticipated start date
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01/05/2008
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Anticipated end date
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30/04/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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286
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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1. The Dunhill Medical Trust (UK)
2. Sanofi-Aventis (UK)
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Trial website
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Publications
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Contact name
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Dr
John
Chambers
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Address
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Cardiothoracic Centre
St Thomas Hospital
Westminster Bridge Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Sponsor
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Guy's and St Thomas NHS Trust (UK)
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Address
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Westminster Bridge Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Sponsor website:
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http://www.guysandstthomas.nhs.uk/
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Date applied
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21/03/2008
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Last edited
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21/04/2008
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Date ISRCTN assigned
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21/04/2008
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