The headache-inducing effects of cilostazol in men and women with migraine without aura

Prior treatment

• Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period
• Concomitant use of anticoagulants, antiaggregants and drugs that inhibit CYP3A4 and CYP2C19 activity
• Assumption of analgesic medications in the 24 hours preceding the experimental days

Other illness

• History or clinical signs of cardiovascular disease, cardiac arrhythmia, unstable angina pectoris, impaired liver function and/or kidney function
• Recent history of myocardial infarction or major cardiac surgery
• Anamnestic or clinical signs of mental illness, abuse or smoking
• Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study
• Known allergy to any component of cilostazol “Aliud”
• Hypertension (> 150/100 mmHg) or hypotension (< 90/50 mmHg) at the Screening Visit

Other

• Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification
• Positive pregnancy test at the Screening and/or before the start of the experiment
• Member of investigational site staff or relative of investigators
• Headache less than 24 hours before the start of the experiment
• Drinking coffee, cola or alcohol less than 8 hours before the start of the experiment

• Healthy men and women with a diagnosis of episodic migraine without aura according to the International Classification
• Age: 18-65 years
• Weight: 50-100 kg
• Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) for women during the entire period of the study
• Fluency in Danish or English