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Study of the effects of pitolisant on migraine without aura in women

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study aims to evaluate the effects of pitolisant on the occurrence of headaches in women who experience migraine without aura. Migraine without aura is a type of severe headache that occurs without the warning signs, such as visual disturbances, that some people experience before a headache starts. Participants may also be taking ibuprofen or sumatriptan, which are common medications used to manage pain or migraine attacks.

During the study, women will be given either pitolisant or a placebo, which is an inactive substance containing gelatin, in the form of an oral tablet. The research will observe how the administration of these substances affects the frequency and intensity of headache symptoms over a period of time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    A single dose of pitolisant (18 mg) is taken orally. pitolisant is the test substance being studied.

    An alternative dose of placebo, which is a substance containing gelatin and has no active medicinal effect, is also taken orally.

  2. Step 2

    Observation of effects

    The occurrence of migraine-like attacks is monitored following the intake of the substance.

    The intensity of any headache is measured over time.

    Any headache, regardless of whether it meets the specific criteria for a migraine, is recorded.

Who can join the trial?

5 criteria

  • You must be a woman who has a history of episodic migraine without aura, which means experiencing recurring headaches that do not involve warning signs like flashes of light or tingling sensations before the pain starts.
  • You must be using a safe method of contraception, which is a way to prevent pregnancy, such as birth control pills, hormonal treatments, or an intrauterine device (IUD), for the entire time you are in the study.
  • You must be between 18 and 65 years old.
  • Your weight must be between 50 and 90 kilograms.
  • You must be able to speak and understand Danish or English fluently.

Who cannot join the trial?

14 criteria

  • Having any other type of headache, except for tension-type headaches (headaches caused by muscle tightness) that occur less than 3 days per month.
  • Having a known allergy (an immune system reaction) to any part of the medicine pitolisant.
  • Being a staff member at the study location or a relative of the doctors running the study.
  • Having had a headache less than 24 hours before the experiment begins.
  • Consuming coffee, cola, or alcohol less than 8 hours before the experiment starts.
  • Taking analgesic medications (pain-relieving medicines like aspirin or ibuprofen) in the 24 hours before the study days.
  • Having a history of or signs of severe psychiatric disorders (serious mental health conditions like anxiety or depression).
  • Having cardiovascular disease (serious heart or blood vessel problems) that is medically significant.
  • Having severe epilepsy (a condition that causes recurring seizures).
  • Having hepatic impairment (liver problems) or renal impairment (kidney problems).
  • Using antihistamines (medicines used to treat allergies), antidepressants (medicines used to treat mood disorders), or specific drugs that affect how the body processes medicine, such as CYP3A4 inducers, CYP2D6 inhibitors, or drugs that interact with the organic cation transporter 1 (OCT1).
  • Having any other medical signs or diseases that the doctor believes would make it unsafe or inappropriate to participate.
  • Using any concomitant medications (other medicines taken at the same time) where the dose has changed in the last 14 days or is expected to change during the study.
  • Having a positive pregnancy test during the initial screening or before the experiment begins.
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Investigated drugs

Pitolisant is the main medication being tested in this study to see if it can cause headaches or migraines in women who already have a history of migraines.

What is already known about the treatment

  • Ibuprofen

    This medication is taken by mouth and is widely used and well-known for treating pain and inflammation. It belongs to a group of drugs called non-steroidal anti-inflammatory drugs. It works by blocking specific enzymes in the body that produce chemicals responsible for causing pain and swelling.

  • Pitolisant

    This medication is taken orally in the form of film-coated tablets and is currently used as a specialized treatment for certain sleep disorders. It is classified as a stimulant that acts on the brain's histamine receptors. By increasing the activity of histamine, it helps to promote wakefulness and alertness at a molecular level.

  • Sumatriptan

    This is an oral medication that is commonly used and established in medical practice for treating migraine attacks. It belongs to a class of drugs known as triptans. It works by narrowing the blood vessels around the brain and affecting certain nerve pathways to stop the pain associated with migraines.

  • Gelatin

    This substance is taken orally and is used here as a placebo, meaning it has no active medicinal effect. It is a common protein used as a neutral base for many pills and capsules. In clinical studies, it serves as a control to ensure that any observed effects are due to the actual medication rather than the act of taking a pill.

Investigated diseases

Migraine without aura - This condition is characterized by recurrent episodes of moderate to severe headache. These attacks often involve pulsing or throbbing sensations, typically on one side of the head. People experiencing this may also feel nausea or sensitivity to light and sound. The episodes can vary in length and intensity. They occur without the visual or sensory disturbances known as an aura.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525521-20-00Estimated enrolment14 patientsSponsorSyddansk Universitet (University of Southern Denmark)

sourced from the EU Clinical Trials Register and site verification

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