Evaluation of the Migraine-Inducing Effects of Pitolisant in Women with Migraine Without Aura
- Trial ID
- 2026-525521-20-00
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the capacity of a single oral administration of pitolisant (18 mg) to induce migraine without aura in female subjects with a documented history of the condition. This study is categorized under safety (4).
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of female patients diagnosed with migraine without aura according to the International Classification. Eligible participants include individuals aged 18 to 65 years with a body weight between 50 and 90 kg. Required inclusion criteria involve the use of safe contraception, such as hormonal therapies or intrauterine devices, for the duration of the study. Additionally, participants must demonstrate fluency in either Danish or English.
Plans and Procedures
This study evaluates the ability of a single oral administration of pitolisant to induce migraine without aura. The research methodology involves the administration of either pitolisant or a placebo to women with a history of episodic migraine. The primary endpoint is the occurrence of migraine-like attacks, while secondary endpoints include headache intensity, measured by the area under the curve, and the occurrence of any headache regardless of diagnostic criteria. The protocol may include the use of sumatriptan and ibuprofen as auxiliary treatments.
Treatment
The investigational product consists of pitolisant administered as 18 mg film-coated tablets via the oral route. This single dose is evaluated for its potential to induce migraine in subjects with a history of migraine without aura.
A placebo containing gelatin is utilized for comparison.
Auxiliary treatments include sumatriptan and ibuprofen.
Efficacy
The primary efficacy endpoint is the occurrence of migraine-like attacks in women with a history of migraine without aura following a single oral administration of pitolisant or placebo.
Secondary endpoints include the following:
- Headache intensity over time, expressed as the area under the curve (AUC).
- The occurrence of any headache, regardless of whether it meets migraine criteria.
Inclusion and Exclusion Criteria
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
- 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), clinically significant cardiovascular disease, severe epilepsy, and hepatic and/or renal impairment
- Concomitant use of antihistamines, antidepressants, strong CYP3A4 inducers, CYP2D6 inhibitors, or drugs that are substrates of the organic cation transporter 1 (OCT1)
- 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
- Positive pregnancy test at the Screening and/or before the start of the experiment
- Known allergy to any component of pitolisant “Wakix”
- Member of investigational site staff or relative of investigators
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Not Yet Recruiting | 01 Aug 2026 | 14 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
IBUPROFEN | Other | — | ORAL | — | — | SUB08098MIG |
Wakix 18 mg film-coated tablets | Test | FILM-COATED TABLETS | ORAL | — | — | PRD6329129 |
SUMATRIPTAN | Other | — | ORAL | — | — | SUB10770MIG |
GELATIN | Placebo | — | ORAL | — | — | SUB12507MIG |