Effect of Ivabradine on Migraine Symptoms Induced by Levcromakalim
Effect of Ivabradine on Levcromakalim-Induced Symptoms in Individuals With Migraine Without Aura: A Randomized Double-Blind Two-Way Crossover Study
This study is testing if Ivabradine can help reduce migraine symptoms caused by Levcromakalim in people who have migraines without aura.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Danish Headache Center Academic / other |
| Locations | 2 sites (Glostrup, Zealand and 1 other locations) |
| Trial ID | NCT04853797 on ClinicalTrials.gov |
What this trial studies
This study investigates how Ivabradine affects migraine symptoms triggered by Levcromakalim in individuals diagnosed with migraine without aura. The research focuses on the role of hyperpolarization-activated cation (HCN) channels in migraine pathophysiology, particularly how their activity may be influenced by cyclic nucleotides and potassium channel activation. Participants will receive either Ivabradine, Levcromakalim, or a placebo to assess the drug's efficacy in alleviating migraine symptoms. The findings aim to enhance understanding of migraine mechanisms and inform future drug development.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of episodic migraine without aura and in good general health.
Not a fit: Patients with tension-type headaches or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for individuals suffering from migraine without aura.
How similar studies have performed: While the specific approach of using Ivabradine in this context is novel, previous studies have explored the role of HCN channels in migraine, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Glostrup, Zealand and 1 other locations
- Danish Headache Centre, Rigshospitalet-Glostrup — Glostrup, Zealand, Denmark (Recruiting)
- Danish Headache Center — Glostrup, Denmark (Recruiting)
Study contacts
- Principal investigator: Messoud Ashina, Prof. — Danish Headache Center
- Study coordinator: Mohammad al-Karagholi, MD
- Email: mahdi.alkaragholi@gmail.com
- Phone: 31191647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.