2026-525987-16-00RecruitingPhase 2
The headache- and migraine-inducing effects of apremilast in women with migraine without aura
Syddansk Universitet (University of Southern Denmark)1 site in 1 country14 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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)
- •Known allergy to any component of apremilast “Stada”
- •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
- •Assumption of analgesic medications in the 24 hours preceding the experimental days
- •History or clinical evidence of severe psychiatric disorders (including anxiety or depression) and hepatic and/or renal impairment
- •Underweight patients (body mass index < 18.5 kg/m²)
- •Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- •Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study
- •Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period
Arms & Interventions
Lactose monohydrate
Placebo
Intervention: Lactose monohydrate (Drug)
Outcomes
Primary Outcomes
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)
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 Outcomes
- 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)
- 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)
- Difference in heart rate and mean arterial pressure (MAP) until 90 minutes post-administration between apremilast- and placebo-treated women with migraine without aura
- 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
Investigators
Clinical Pharmacology, Pharmacy and Environmental Medicine
Scientific
Syddansk Universitet (University of Southern Denmark)
Study Sites (1)
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