CILOSTAZOL for Migraine | Migraine without aura | Episodic migraine without aura

Inclusion criteria

• {"criterion_text":"- Healthy men and women with a diagnosis of episodic migraine without aura according to the International Classification\n- Age: 18-65 years\n- Weight: 50-100 kg\n- Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) for women during the entire period of the study\n- 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\n- Concomitant use of anticoagulants, antiaggregants and drugs that inhibit CYP3A4 and CYP2C19 activity\n- Positive pregnancy test at the Screening and/or before the start of the experiment\n- Known allergy to any component of cilostazol “Aliud”\n- Member of investigational site staff or relative of investigators\n- Headache less than 24 hours before the start of the experiment\n- Drinking coffee, cola or alcohol less than 8 hours before the start of the experiment\n- Assumption of analgesic medications in the 24 hours preceding the experimental days\n- Hypertension (> 150/100 mmHg) or hypotension (< 90/50 mmHg) at the Screening Visit\n- History or clinical signs of cardiovascular disease, cardiac arrhythmia, unstable angina pectoris, impaired liver function and/or kidney function\n- Recent history of myocardial infarction or major cardiac surgery\n- Anamnestic or clinical signs of mental illness, abuse or smoking\n- Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study\n- Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period"}

Primary endpoints

• {"endpoint_text":"- The difference in the incidence of migraine-like attacks during the entire observational period (until 12 hours post-administration) between cilostazol- and placebo-treated men with migraine without aura","definition_or_measurement_approach":"Incidence of migraine-like attacks measured during the entire observational period up to 12 hours post-administration; comparison between cilostazol and placebo in men."}
• {"endpoint_text":"- The difference in the incidence of migraine-like attacks during the entire observational period (until 12 hours post-administration) between cilostazol-treated men and women with migraine without aura","definition_or_measurement_approach":"Incidence of migraine-like attacks measured during the entire observational period up to 12 hours post-administration; comparison between cilostazol-treated men and cilostazol-treated women."}

Secondary endpoints

• {"endpoint_text":"- The difference in the incidence of headache during the entire observational period (until 12 hours post-administration) between cilostazol- and placebo-treated men with migraine without aura","definition_or_measurement_approach":"Incidence of headache measured during the observational period up to 12 hours post-administration; comparison between cilostazol and placebo in men."}
• {"endpoint_text":"- Difference in heart rate and mean arterial pressure until 90 minutes post-administration between cilostazol- and placebo-treated men with migraine without aura","definition_or_measurement_approach":"Change/difference in heart rate and mean arterial pressure measured up to 90 minutes after administration; comparison between cilostazol and placebo in men."}
• {"endpoint_text":"- Difference in the incidence of adverse events during the entire observational period (until 12 hours post-administration) between cilostazol- and placebo-treated men with migraine without aura","definition_or_measurement_approach":"Incidence of adverse events recorded during the observational period up to 12 hours post-administration; comparison between cilostazol and placebo in men."}

Denmark

Earliest CTIS Part Ii Submission Date

15-05-2025

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

36

Number Of Sites

1

Number Of Participants

29

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":"1","organisation_type":"Hospital/Clinic/Other health care facility"}