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

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What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Syddansk Universitet (University of Southern Denmark)	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.08.2026

Trial locations

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.

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 ID:

2026-525521-20-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?