Effect of Ivabradine on Levcromakalim-Induced Symptoms in Individuals With Migraine Without Aura (ILIM)

Launched by DANISH HEADACHE CENTER · Apr 18, 2021

Keywords

ClinConnect Summary

This clinical trial, called ILIM, is studying how a medication called Ivabradine affects people who experience migraines without aura, which means they have migraines but do not experience warning signs like visual disturbances before the headache starts. The researchers want to see if Ivabradine can help reduce symptoms triggered by another substance called Levcromakalim. They are currently looking for participants aged 18 to 60 who are generally healthy, have a diagnosis of episodic migraine without aura, and meet certain health criteria.

To participate, individuals must be able to provide written consent and should not have any serious health issues, such as heart or brain conditions. Participants should also not be taking any long-term medications or have a history of specific types of headaches other than migraines without aura. Those who qualify will be involved in the study to help researchers understand the potential benefits of Ivabradine. It’s important to note that if you're considering joining this trial, you should be comfortable with the possibility of receiving information about any significant health findings during the study.

Gender

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Eligibility criteria

• 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 intolerant (due to Ivabradine tablets containing lactose).
• • Have a daily intake of any medicine other than oral contraception or use of drugs or other ed-ibles/beverages with potential serious interactions with ivabradine
• • Have a history of personal/familial or clinical signs of: cardiovascular and cerebrovascular disease (Long QT Syndrome, Cardiac dysrhythmia, Bradycardia, i.e. a resting heart rate of \< 60 bpm at screening, Amnestic information or clinical signs of hyper- or hypotension (Hypertension (systolic blood pressure \> 150 mmHg and / or diastolic blood pressure \> 100 mmHg)/Hypotension (systolic blood pressure \< 90 mm Hg and / or diastolic blood pressure \< 50 mmHg)), Heart failure (NYHA II or higher)); Psychiatric conditions; Drug abuse of any kind; Smoking; Other comorbidities or clinical signs of diseases of any kind considered by the investigating physician to make the participant ineligible because of safety concerns).
• • Are pregnant, breastfeeding or not using appropriate contraception.
• • Do not want any information on significant pathological findings in the study.