Pitolisant for Migraine without aura

Inclusion criteria

• {"criterion_text":"- Healthy women with a diagnosis of episodic migraine without aura according to the International Classification"}
• {"criterion_text":"- Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) during the entire period of the study"}
• {"criterion_text":"- Age: 18-65 years"}
• {"criterion_text":"- Weight: 50-90 kg"}
• {"criterion_text":"- Fluency in Danish or English"}

Exclusion criteria

• {"criterion_text":"- Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification"}
• {"criterion_text":"- Known allergy to any component of pitolisant “Wakix”"}
• {"criterion_text":"- Member of investigational site staff or relative of investigators"}
• {"criterion_text":"- Headache less than 24 hours before the start of the experiment"}
• {"criterion_text":"- Drinking coffee, cola or alcohol less than 8 hours before the start of the experiment"}
• {"criterion_text":"- Assumption of analgesic medications in the 24 hours preceding the experimental days"}
• {"criterion_text":"- History or clinical evidence of severe psychiatric disorders (including anxiety or depression), clinically significant cardiovascular disease, severe epilepsy, and hepatic and/or renal impairment"}
• {"criterion_text":"- Concomitant use of antihistamines, antidepressants, strong CYP3A4 inducers, CYP2D6 inhibitors, or drugs that are substrates of the organic cation transporter 1 (OCT1)"}
• {"criterion_text":"- Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study"}
• {"criterion_text":"- Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period"}
• {"criterion_text":"- Positive pregnancy test at the Screening and/or before the start of the experiment"}

Primary endpoints

• {"endpoint_text":"- The occurrence of migraine-like attacks in pitolisant- and placebo-treated women with migraine without aura","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Headache intensity over time, expressed as the area under the curve (AUC), following pitolisant and placebo administration in women with migraine without aura","definition_or_measurement_approach":"Headache intensity measured over time and expressed as area under the curve (AUC) following administration."}
• {"endpoint_text":"- The occurrence of any headache, irrespective of migraine criteria, following pitolisant and placebo administration","definition_or_measurement_approach":"Recording occurrence of any headache following administration."}

Denmark

Earliest CTIS Part Ii Submission Date

24-03-2026

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

2

Number Of Sites

1

Number Of Participants

14

Primary sponsor

Full Name

Syddansk Universitet (University of Southern Denmark)

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"Sponsor duties (code 1)","organisation_type":"Hospital/Clinic/Other health care facility"}