2026-525987-16-00Not yet recruitingPhase 1/2
The headache- and migraine-inducing effects of apremilast in women with migraine without aura
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 29 May 2026
- Start date
- 1 Oct 2026
- Lead sponsor
- Syddansk Universitet (University of Southern Denmark)
- Diseases
- Migraine
- EU CT number
- 2026-525987-16-00
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 to 65 with episodic migraine without aura, who are otherwise healthy. It tests whether a single dose of apremilast (30 mg) can trigger migraine.
- Age
- 18-65 years (the registry header lists 18 to 64 years)
- Sex
- Women only
- Disease stage
- Episodic migraine without aura, diagnosed by the International Classification.
- Earlier treatment
- No pain medicine in the 24 hours before the test days. No change in the dose of other medicines within 14 days before screening.
Main reasons for not taking part
- Any other type of headache (except under 3 days of tension-type headache a month)
- Positive pregnancy test
- Known allergy to a component of apremilast “Stada”
- Severe psychiatric disorders (including anxiety or depression), or liver or kidney problems
- Body mass index under 18.5 kg/m²
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
- 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 apremilast “Stada”
- History or clinical evidence of severe psychiatric disorders (including anxiety or depression) 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
Lab values
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
Other
- Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification
- Positive pregnancy test at the Screening and/or before the start of each experimental day (first and second experimental administration)
- 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
- Underweight patients (body mass index < 18.5 kg/m²)
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.