Evaluating the effectiveness and tolerability of migraine treatments
Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP): an International Prospective Multicentric Cohort Study
This study is testing how well different migraine treatments work and how easy they are to handle for people who suffer from migraines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clínico Universitario de Valladolid Academic / other |
| Locations | 1 site (Valladolid) |
| Trial ID | NCT06267664 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world effectiveness and tolerability of various acute migraine treatments, including triptans, Lasmiditan, and gepants. It will involve a prospective cohort of patients who meet the criteria for migraine as defined by the International Classification of Headache Disorders. Participants will report their experiences with these treatments in routine clinical practice, focusing on pain freedom and the absence of bothersome symptoms. The study will also explore predictors of treatment response and tolerability.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with migraine who are being treated with triptans, Lasmiditan, or gepants.
Not a fit: Patients using opioids, barbiturates, or ergot derivatives, or those with major cognitive or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective and tolerable migraine treatments for patients in everyday clinical settings.
How similar studies have performed: Other studies have shown success in evaluating migraine treatments, but this study focuses on real-world effectiveness, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fulfill the criteria for migraine, according to the International Classification of Headache Disorders, 3rd version; * Treatment with triptans, Lasmiditan or Gepants as acute therapies according to their responsible physician criteria under routine clinical practice criteria; * Participant have a smartphone, tablet, or computer with an internet connection; * Participant accept to participate and sign the informed consent form Exclusion Criteria: * Patient have a concomitant use of opioids, barbiturates, or ergot derivates; * Participant have major cognitive or psychiatric disorder; * Participants are unable to describe the result of the employed drug * Participants have an insufficient proficiency of the local languages.
Where this trial is running
Valladolid
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Study coordinator: David García Azorín, MD, PhD
- Email: davilink@hotmail.com
- Phone: +34665872228
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.