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Study of apremilast‑induced headache and migraine in women with migraine without aura

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves women who experience Migraine without aura, a common type of severe headache that is not preceded by visual or sensory warning signs. The medication being tested is a single oral dose of 30 mg of Apremilast, a tablet taken by mouth, and it will be compared with an inactive tablet known as placebo. Participants will receive either the active tablet or the inactive one and will be observed for up to 12 hours after taking the dose.

The purpose of the study is to see whether a single dose of the medication can trigger migraine attacks in this group of women. After taking the tablet, participants will stay in a comfortable setting where their headache intensity, any occurrence of headache, heart rate (the number of beats per minute), and mean arterial pressure (a measure of overall blood pressure) will be recorded at regular intervals. Any side effects or unwanted symptoms that appear during the observation period will also be noted.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and medication assignment

    After enrollment, the participant is assigned to receive either apremilast 30 mg or a matching placebo (lactose monohydrate). the assignment is done by the study staff and is not influenced by the participant.

  2. Step 2

    Single oral dose administration

    The participant takes one film‑coated tablet by mouth on the study day. the tablet contains either apremilast 30 mg or the inert placebo. the dose is taken once and no additional doses are required.

  3. Step 3

    Early vital‑sign monitoring

    For the first 90 minutes after taking the tablet, the participant’s heart rate and mean arterial pressure (a measure of blood pressure) are measured at regular intervals. this monitoring helps assess any immediate effects of the medication.

  4. Step 4

    Headache and migraine observation

    The participant monitors and records any headache or migraine symptoms for up to 12 hours after the dose. recordings include the time of onset, intensity of pain, and any other relevant characteristics. the observation period ends 12 hours after the tablet is taken.

  5. Step 5

    Adverse‑event reporting

    Throughout the 12‑hour observation period, the participant notes any unwanted effects or health changes, such as nausea, dizziness, or other symptoms, and reports them according to the study instructions.

  6. Step 6

    Completion of observation

    After the 12‑hour period, the observation phase is finished. the participant may be asked to complete final questionnaires about the experience, after which no further study procedures are required.

Who can join the trial?

5 criteria

  • Healthy women who have been diagnosed with episodic migraine without aura (migraine attacks that happen occasionally and do not have warning signs) according to a standard set of diagnostic rules.
  • Safe contraception must be used throughout the study. This includes methods such as hormonal therapies, intrauterine devices, or oral birth‑control pills to prevent pregnancy.
  • Age between 18 and 65 years old.
  • Weight between 50 and 90 kilograms (about 110 to 200 pounds).
  • Fluency in Danish or English, meaning you can read, understand, and speak one of these languages well enough to follow study instructions.

Who cannot join the trial?

12 criteria

  • Having any other type of headache (except occasional tension‑type headache that occurs fewer than 3 days per month). This means you must not have migraines or other headache disorders besides the study’s target condition.
  • Positive pregnancy test at screening or before any experimental day. A pregnancy test that shows you are pregnant makes you ineligible.
  • Known allergy to any part of the study drug apremilast (brand “Stada”). If you are allergic to the medication, you cannot join.
  • Being a staff member at the research site or a relative of the investigators. Family members or employees of the study team are excluded.
  • Having a headache less than 24 hours before the experiment starts. You must be headache‑free for at least one day before testing.
  • Drinking coffee, cola, or alcohol less than 8 hours before the experiment. You need to avoid these beverages for at least eight hours prior.
  • Taking pain‑relieving medicines (analgesics) within the 24 hours before the experimental days. Use of any medication for pain disqualifies participation.
  • History or current signs of severe mental health problems such as anxiety or depression, or having serious liver (hepatic) or kidney (renal) disease. These conditions make participation unsafe.
  • Being underweight, defined as a body mass index (BMI) lower than 18.5 kg/m². BMI is a calculation using your height and weight.
  • Having rare inherited conditions that affect sugar processing, such as galactose intolerance, total lactase deficiency, or glucose‑galactose malabsorption. These genetic disorders exclude you.
  • Showing any past or current signs of other diseases that the doctor believes could affect the study. Any additional illness deemed relevant by the investigator prevents enrollment.
  • Using other medicines that have had their dose changed in the past 14 days before screening or are expected to change during the study (concomitant medications). Stable medication regimens are required.
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Investigated drugs

Apremilast is an oral medication taken as a film‑coated tablet. In this study it is the test drug that participants will take once to see whether it can cause a migraine attack in women who usually have migraine without aura. The researchers are looking at how this medicine might trigger headache symptoms when given in a single dose.

What is already known about the treatment

  • Apremilast

    Apremilast is taken as a film‑coated tablet swallowed by mouth; it is an approved oral medicine mainly used for plaque psoriasis and psoriatic arthritis and is well documented in medical literature. It works by blocking an enzyme called phosphodiesterase‑4, which raises levels of a natural molecule that reduces inflammation. Because it lowers inflammation, doctors use it to treat skin and joint problems, and researchers are now studying whether a single 30 mg dose can trigger migraine attacks. It belongs to the class of phosphodiesterase‑4 inhibitors, a type of anti‑inflammatory drug.

  • Lactose monohydrate

    Lactose monohydrate is a simple sugar powder that is used in the trial as an inactive tablet that looks like the real medicine; it is taken orally just like the test drug. It has no therapeutic effect and is not a drug in medical practice, so it appears only as a filler in many tablets. In this study it serves as a placebo to compare the effects of apremilast with a substance that does nothing. It is classified as an excipient, a non‑medicinal ingredient used to make tablets.

Investigated diseases

Migraine without aura - A recurrent headache disorder marked by moderate to severe throbbing pain, usually on one side of the head, lasting from four to seventy‑two hours. It is often accompanied by nausea, vomiting, and increased sensitivity to light or sound, but it does not include the visual or sensory disturbances known as aura. The attacks typically develop gradually and may become more frequent or intense over time, often triggered by stress, hormonal changes, certain foods, or changes in sleep patterns.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525987-16-00Estimated enrolment14 patientsSponsorSyddansk Universitet (University of Southern Denmark)

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