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Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP)

NCT06267664 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2024-02-21

No results posted yet for this study

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.

Conditions

  • Migraine
  • Migraine Disorders
  • Migraine With Aura
  • Headache Disorders

Interventions

DRUG

Patients with migraine treated with triptans, Lasmiditan or Gepants

Patients will complete the study information in their smartphones, tablets or computers, using a QR code or a link that will redirect hem to the study questionnaires. RedCap will be used in the study.

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valladolid

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-09-30
Completion
2024-12-01
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267664 on ClinicalTrials.gov