Evaluating the effectiveness of lasmiditan for treating migraines
Effectiveness and Tolerability of Lasmiditan as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study
This study is testing if lasmiditan can help people with migraines feel better during their attacks and if it's safe for those with heart issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Locations | 2 sites (Florence and 1 other locations) |
| Trial ID | NCT05903040 on ClinicalTrials.gov |
What this trial studies
This multicentric observational study aims to assess the effectiveness and tolerability of lasmiditan, a serotonin 5-HT1F receptor agonist, in treating acute migraine attacks in patients with episodic or chronic migraines. Participants will take lasmiditan in varying doses (50, 100, or 200 mg) during their next migraine attack, with data collected at baseline and during follow-up assessments after each attack. The study will focus on real-world effectiveness and tolerability, particularly in patients with cardiovascular histories who may benefit from lasmiditan's lack of vasoconstrictive activity. Adverse events will also be monitored, particularly those related to the central nervous system.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with migraine without aura, migraine with aura, or chronic migraine who experience at least three migraine days per month.
Not a fit: Patients with contraindications for ditans or those with comorbidities that may interfere with study assessments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for migraine patients, especially those with cardiovascular concerns.
How similar studies have performed: Previous studies have shown promising results for lasmiditan in treating migraines, indicating that this approach has potential based on earlier findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III). At least 3 MMDs * Good compliance to study procedures * Availability of headache diary at least of the preceding months before enrollment Exclusion Criteria: * Subjects with contraindications for use of ditans; * Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments; * medical comorbidities that could interfere with study results; * Pregnancy and breastfeeding.
Where this trial is running
Florence and 1 other locations
- SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi — Florence, Italy (Recruiting)
- IRCCS National Neurological Institute "C. Mondino" Foundation — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Luigi F Iannone
- Email: luigifrancesco.iannone@unifi.it
- Phone: +393896969606
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.