Clopidogrel as prophylactic treatment for migraine

ISRCTN	ISRCTN35114412
DOI	https://doi.org/10.1186/ISRCTN35114412
Secondary identifying numbers	Version 05

Submission date: 21/03/2008
Registration date: 21/04/2008
Last edited: 17/11/2014

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 John Chambers
Scientific

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

Study information

Study design	Randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2008
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cardiothoracic Centre

London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St Thomas NHS Trust (UK)
Hospital/treatment centre

Westminster Bridge Road
London
SE1 7EH
England
United Kingdom

Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Charity

The Dunhill Medical Trust (UK)

No information available

Sanofi-Aventis (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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