Trip-Tox Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine

  • STATUS
    Recruiting
  • End date
    Sep 25, 2022
  • participants needed
    100
  • sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Updated on 10 October 2021

Summary

Observational, longitudinal, prospective, prospective, comparative study of the effectiveness of triptans before and after onabotulintoxin A initiation in a single group of chronic migraine patients.

Description

Hypothesis In patients with chronic migraine the efficacy of triptans, previously taken by the patient for the migraine attack, is better and more satisfactory after starting treatment with onabotulinumtoxinA.

Objectives To analyze the efficacy and satisfaction of the triptan usually taken by the patient with chronic migraine before starting preventive treatment with onabotulinumtoxinA, at 4 months, after two sessions of Botox, and at 7 months of treatment, after three sessions of Botox.

Sample size n=100 patients with chronic migraine in whom treatment with onabotulinumtoxinA is indicated. The indication for Botox treatment will be performed as usual and the patient will take his usual triptan if he has a migraine attack, so there is no therapeutic modification in this study that could involve any bioethical issue.

All patients signed the informed consent and the study was approved by the Comit d'tica de la Investigaci amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.

Details
Condition Chronic Migraine
Treatment OnabotulinumtoxinA
Clinical Study IdentifierNCT04871152
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ICHD-3 criteria for chronic migraine (code 1.3). See Table 3
Older than 18 years and younger than 65 years
Migraine started in their lifetime before the age of 50 years
Migraine of more than one year of evolution since diagnosis
Normal cranial CT/MRI study
Indication for treatment with Botox
Taking triptans as a rescue treatment for migraine attacks

Exclusion Criteria

Pregnant women
Migraine of less than one year of evolution since diagnosis
Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies)
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