Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP): an International Prospective Multicentric Cohort Study

PI-GR-23-3263

Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs. The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study. This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors. The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes.

2023-12-04

2024-09-30

2024-12-01

Recruiting

1500

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '14 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}

2024-02-21