The headache- and migraine-inducing effects of pitolisant in women with migraine without aura
Key facts
- Where
- Odense M, DániaSee the site
- Phase
- 1/2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Dánia
- Syddansk Universitet (University of Southern Denmark)Odense M, DániaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Syddansk Universitet (University of Southern Denmark)
- Trial code
- EU 2026-525521-20-00
- Record updated
- 2026. március 26.
- Original description
We will test the ability of a single oral administration of pitolisant (18 mg) to induce migraine in women with a history of migraine without aura.Read full original descriptionShow less
We will test the ability of a single oral administration of pitolisant (18 mg) to induce migraine in women with a history of migraine without aura.
Inclusion: 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.
Exclusion: 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.