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

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Contents

clinicaltrials.gov/study/NCT06267664
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT062676640
Health Conditions in Trial
Migraine
Migraine
0
Trial Recruitment Size
1,5000
Clinical Trial Start Date
December 4, 2023
0
Primary Completion Date
September 30, 2024
0
Study Completion Date
December 1, 2024
0
Clinical Trial Study Type
Observational0
Intervention Type
Drug0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Official Name
Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP): an International Prospective Multicentric Cohort Study0
Last Updated
February 21, 2024
0

Other attributes

Intervention Treatment
Patients with migraine treated with triptans, Lasmiditan or Gepants0
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.

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