Migraine MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants aged > 18 Definite migraine with or without aura as defined by International Headache criteria Headache or aura occurring on 4 or more days and less than 15 days in a 28 day month Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: High risk features suggesting cerebral malignancy, More than 15 headache days each month Contraindications to clopidogrel therapy (hypersensitivity, active bleeding, warfarin therapy, hepatic dysfunction) Already prescribed clopidogrel (recent acute coronary syndrome, TIA with aspirin hypersensitivity) Requirement for routine nonsteroidal anti-inflammatory agents (occaisional use is allowed) Use of an investigational product within the previous 3 months Clinically significant abnormal platelet or liver function at visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the incidence of 'patent ovale and atrial septal aneurysm in consecutive migraineurs. 2. To test whether Clopidogrel is effective prophylaxisi in consecutive migraineurs 3. To determine the effect of a patent foramen ovale or atrial septal aneurysm on the efficacy of clopidogrel. 4. To compare efficacy of Clopidogrel in migraine with and without aura.;Secondary Objective: ;Primary end point(s): The number of headache days in 28 days Secondary: (1) The severity and (2) duration of migraine attacks in 28 days and the number of responders. | — |
Countries
United Kingdom