Effect of Ivabradine on Levcromakalim-Induced Symptoms in Individuals With Migraine Without Aura … (NCT04853797) | Clinical Trial Compass
CompletedNot Applicable
Effect of Ivabradine on Levcromakalim-Induced Symptoms in Individuals With Migraine Without Aura (ILIM)
Denmark37 participantsStarted 2021-05-11
Plain-language summary
This study aims to explore the effect of Ivabradine on Levcromakalim-induced migraine in individuals with migraine without aura.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be able to give voluntary written informed consent to participate.
* Have a diagnosis of episodic migraine without aura according to The International Classification of Headache Disorders 3rd Edition.
* Be in good general health and without any cardio- or cerebrovascular diseases, psychiatric disorders or other severe comorbidities.
* Be 18-60 years of age.
* Have a weight between 50-100 kg.
* Have a normal standard resting 12-lead ECG at the screening visit with heart rate (HR) ≥ 60 bpm (the inclusion criterium of HR ≥ 60 bpm at screening has previously been used in studies with dosages of ivabradine up to 20 mg as single and multiple doses with no significant adverse events).
* Be without any chronic use of medicine.
* Have a negative urine-human chorionic gonadotropin (hCG) test at the screening visit if they are female of childbearing potential.
Exclusion Criteria:
* Suffer from tension type headache, as defined by the The International Classification of Headache Disorders 3rd Edition, more than five days a month on average in the last year.
* Are diagnosed with any primary headache disorder apart from migraine without aura as de-fined in The International Classification of Headache Disorders 3rd Edition (relating to tension type headache, see above).
* Suffer from any headache 48 hours prior to the start of the experiment or any migraine 72 hours prior to the start of the experiment.
* Are allergic to ivabradine or levcromakalim.
* Are lactose in…
What they're measuring
1
Incidence of migraine attacks
Timeframe: Assessed from baseline to 12 hours after infusion of levcromakalim