Trip-Tox, Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine
NCT ID: NCT04871152
Last Updated: 2021-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-03-25
2022-09-25
Brief Summary
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Detailed Description
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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 Comitè d'Ètica de la Investigació amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with chronic migraine
In the same group of patients, the response to triptans will be analyzed at 3 different times with respect to the start of treatment with onabotulinumtoxinA: before treatment, after 4 months and after 7 months of treatment.
OnabotulinumtoxinA
To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.
Interventions
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OnabotulinumtoxinA
To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Migraine of less than one year of evolution since diagnosis.
* Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies).
18 Years
65 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Robert Belvís, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Locations
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Headache and Neuralgia Unit. Neurology Department. Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIBSP-TOX-2020-67
Identifier Type: -
Identifier Source: org_study_id
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