Clopidogrel as prophylactic treatment for migraine

Completed

• Conditions: Migraine; Nervous System Diseases

• Registration Number: ISRCTN35114412
• Lead Sponsor: Guy's and St Thomas NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 286

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Frequency of attacks<br>2. Severity of attacks<br>3. Duration of attacks<br><br>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.