Condition category
Nervous System Diseases
Date applied
21/03/2008
Date assigned
21/04/2008
Last edited
17/11/2014
Prospective/Retrospective
Prospectively 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 John Chambers

ORCID ID

Contact details

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

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 measures

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

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

http://www.guysandstthomas.nhs.uk/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24836213

Publication citations

  1. 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.

Additional files

Editorial Notes