Clopidogrel as prophylactic treatment for migraine

ISRCTN	ISRCTN35114412
DOI	https://doi.org/10.1186/ISRCTN35114412
Protocol serial number	Version 05
Sponsor	Guy's and St Thomas NHS Trust (UK)
Funders	The Dunhill Medical Trust (UK), Sanofi-Aventis (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr John Chambers
Scientific

Cardiothoracic Centre
St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Primary study design	Interventional
Study design	Randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	That clopidogrel is effective for the prophylaxis of migraine with or without the presence of a patent foramen ovale.
Ethics approval(s)	Ethics approval received from Guy's Hospital Ethics Committee on the 17th December 2007 (ref: 07/H0804/139).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Clopidogrel
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/04/2011

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	286
Key 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
Key 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
Date of first enrolment	01/05/2008
Date of final enrolment	30/04/2011

Cardiothoracic Centre

London
SE1 7EH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2014		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes