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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
David García Azorín, MD, PhD
davilink@hotmail.com
+34665872228
Backup
Yesica González Osorio
yesgonzalezosorio@outlook.com
634330426
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 1500
Treatments
Patients with migraine treated with triptans, Lasmiditan or Gepants
Patients that fulfill the criteria for migraine, according to the International Classification of Headache Disorders, 3rd version treated with triptans, Lasmiditan or Gepants as acute therapies according to their responsible physician criteria under routine clinical practice criteria
Sponsors
Leads: Hospital Clínico Universitario de Valladolid

This content was sourced from clinicaltrials.gov

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