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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Syddansk Universitet (University of Southern Denmark)

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-03-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

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.

Conditions and MedDRA coding

Migraine without aura

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 11

1. Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification
2. Headache less than 24 hours before the start of the experiment
3. Drinking coffee, cola or alcohol less than 8 hours before the start of the experiment
4. Assumption of analgesic medications in the 24 hours preceding the experimental days
5. History or clinical evidence of severe psychiatric disorders (including anxiety or depression), clinically significant cardiovascular disease, severe epilepsy, and hepatic and/or renal impairment
6. Concomitant use of antihistamines, antidepressants, strong CYP3A4 inducers, CYP2D6 inhibitors, or drugs that are substrates of the organic cation transporter 1 (OCT1)
7. Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study
8. Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period
9. Positive pregnancy test at the Screening and/or before the start of the experiment
10. Known allergy to any component of pitolisant “Wakix”
11. Member of investigational site staff or relative of investigators

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The occurrence of migraine-like attacks in pitolisant- and placebo-treated women with migraine without aura

Secondary endpoints 2

1. Headache intensity over time, expressed as the area under the curve (AUC), following pitolisant and placebo administration in women with migraine without aura
2. The occurrence of any headache, irrespective of migraine criteria, following pitolisant and placebo administration

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Syddansk Universitet (University of Southern Denmark)

Sponsor organisation

Syddansk Universitet (University of Southern Denmark)

Address

Campusvej 55

City

Odense M

Postcode

5230

Country

Denmark

Scientific contact point

Organisation

Syddansk Universitet (University of Southern Denmark)

Contact name

Lanfranco Pellesi

Public contact point

Organisation

Syddansk Universitet (University of Southern Denmark)

Contact name

Lanfranco Pellesi

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications