Effect of Riocigaut on Migraine Attack Induction and Cerebral Vasodilation in Migraine Patients.

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This double-blind, randomized, placebo-controlled cross-over clinical trial aims to investigate the effects of riocigaut on migraine inducing properties and cerebral arteries in patients with migraine.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Riociguat

Criteria

Inclusion Criteria:

• A history of migraine without aura for ≥ 12 months according to the classification criteria of the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria.

• Ability to provide written informed consent and receive participant privacy and rights information prior to initiation of any study-specific activities.

• Male or female participants aged 18-45 years at screening.

• No migraine preventive treatment at screening or during study conduction.

• Non-smokers

Exclusion Criteria:

• Any current or previous history of other primary or secondary headache disorder(s) apart from tension type headache ≤ 5 days per month.

• Lack of ability to differentiate migraine from other headaches

• Headache within 24 hours before any study related procedures (Provocation Day 1 and Provocation Day 2) - Subjects are however allowed to be re-booked for provocation days according to allowed timelines.

• Any daily medication apart from contraceptives.

• Use of any antihypertensive, nitrates or nitric oxide donors or phosphodiesterase inhibitors, CYP3A4 and P-glycoprotein inhibitors, HIV-proteaseinhibitors, ciclosporin A or CYP1A1-inhibitors, antacida and acid-neutreulizing agents (such as aluminium-/magnesiumhydroxid), CYP3A4-inductors (such as bosentan, phenytoin, carbamazepin, phenobarbital and herbal remedies with perikon).

• Intake of any pro necessitate medication later than 4 times plasma half-life for the specific drug before study start.

• Women of child-bearing potential not currently using safe contraceptives. Women of child-bearing potential does not include hysterectomized women and women who have been in menopause for at least 2 years. Safe contraceptives include either IUD, birth control pills, surgical sterilization of the woman, depositary gestagen, barrier prevention or sexual abstinence.

• Pregnant or breastfeeding women

• Positive pregnancy urine screening on screening day or provocation days.

• A medical history or clinical signs of

• Hypertension (systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg)

• Hypotension (systolic blood pressure <100mmHg and/or diastolic blood pressure <50mmHg)

• Electrocardiogram (ECG) with any clinically significant abnormalities at screening determined by the investigator, including but not limited to, prolonged PQ or QTc interval, signs of arrythmias, ischemia or left/right ventricle dysfunction/hypertrophy.

• A medical history or clinical signs of pulmo-/cardiovascular disease including cerebrovascular disease.

• A family history of severe cardiac disease.

• A medical history or clinical signs of clinically significant psychiatric illness per investigator opinion.

• The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior.

• A medical history or clinical signs of substance or alcohol abuse

• A medical history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion.

• Any history of hypersensitivity to riociguat.

• Subjects who do not want information about crucial pathological findings during the study

• Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge.