Status:
COMPLETED
Effect of Ivabradine on Levcromakalim-Induced Symptoms in Individuals With Migraine Without Aura (ILIM)
Lead Sponsor:
Danish Headache Center
Conditions:
Headache
Migraine Without Aura
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study aims to explore the effect of Ivabradine on Levcromakalim-induced migraine in individuals with migraine without aura.
Detailed Description
Hyperpolarization-activated cation (HCN) channels have recently been implicated in neuropathic and inflammatory pain processes through their hyperfunction and/or overexpression. HCN channels may play...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04853797
Start Date
May 11 2021
End Date
July 6 2025
Last Update
January 8 2026
Active Locations (2)
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1
Danish Headache Centre, Rigshospitalet-Glostrup
Glostrup, Region Sjælland, Denmark, 2600
2
Danish Headache Center
Glostrup Municipality, Denmark, 2600