Testing pitolisant for migraine-triggering effects in women with migraine

Who can take part

• Healthy women with a diagnosis of episodic migraine without aura according to the International Classification
• Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) during the entire period of the study
• Age: 18-65 years
• Weight: 50-90 kg
• Fluency in Danish or English

Who cannot take part

• Assumption of analgesic medications in the 24 hours preceding the experimental days
• Concomitant use of antihistamines, antidepressants, strong CYP3A4 inducers, CYP2D6 inhibitors, or drugs that are substrates of the organic cation transporter 1 (OCT1)
• Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period
• Known allergy to any component of pitolisant “Wakix”
• History or clinical evidence of severe psychiatric disorders (including anxiety or depression), clinically significant cardiovascular disease, severe epilepsy, and hepatic and/or renal impairment
• Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study
• Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification
• 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
• Positive pregnancy test at the Screening and/or before the start of the experiment