The headache- and migraine-inducing effects of apremilast 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)

2026-07-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

A.P. Møller Fonden

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

We will test the ability of a single oral administration of apremilast (30 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 12

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) and hepatic and/or renal impairment
6. Underweight patients (body mass index < 18.5 kg/m²)
7. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
8. Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study
9. Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period
10. Positive pregnancy test at the Screening and/or before the start of each experimental day (first and second experimental administration)
11. Known allergy to any component of apremilast “Stada”
12. Member of investigational site staff or relative of investigators

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in the occurrence of migraine-like attacks between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration)

Secondary endpoints 4

1. Difference in headache intensities over time between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration)
2. The occurrence of any headache, irrespective of migraine criteria, between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration)
3. Difference in heart rate and mean arterial pressure (MAP) until 90 minutes post-administration between apremilast- and placebo-treated women with migraine without aura
4. Difference in the incidence of adverse events during the entire observational period (until 12 hours post-administration) between apremilast- and placebo-treated women with migraine without aura

Investigational products

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

Test 1

Placebo 1

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

Clinical Pharmacology, Pharmacy and Environmental Medicine

Public contact point

Organisation

Syddansk Universitet (University of Southern Denmark)

Contact name

Clinical Pharmacology, Pharmacy and Environmental Medicine

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 10 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