2026-525521-20-00Not yet recruitingPhase 1/2
The headache- and migraine-inducing effects of pitolisant in women with migraine without aura
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 28 Feb 2026
- Start date
- 1 Aug 2026
- Lead sponsor
- Syddansk Universitet (University of Southern Denmark)
- Diseases
- Migraine
- EU CT number
- 2026-525521-20-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 14
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18-65 who have episodic migraine without aura. It tests whether one oral dose of pitolisant (18 mg) can bring on migraine.
- Age
- 18-65 years (the registry also lists 18 to 64 years).
- Sex
- Women only.
- Disease stage
- Episodic migraine without aura, diagnosed according to the International Classification.
- Earlier treatment
- No pain medicine in the 24 hours before the test days. No change in the dose of other regular medicines within 14 days before screening.
Main reasons for not taking part
- Any other type of headache (except tension-type headache on fewer than 3 days a month)
- Known allergy to any component of pitolisant 'Wakix'
- Severe psychiatric disorder, clinically significant heart disease, severe epilepsy, or liver or kidney problems
- Use of antihistamines, antidepressants, strong CYP3A4 inducers, CYP2D6 inhibitors, or OCT1 substrate drugs
- Positive pregnancy test at screening or before the test
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Syddansk Universitet (University of Southern Denmark) | Odense M | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.