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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Comitè d'Ètica de la Investigació amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.

Official Title
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Trip-tox Study. Analysis of the Efficacy and Satisfaction of Symptomatic Treatment With Triptans in Patients With Chronic Migraine Undergoing onabotulinumtoxinA Treatment

Conditions
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Chronic Migraine

Intervention / Treatment
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* Drug: OnabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic migraine<br>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. | Drug: OnabotulinumtoxinA<br>* To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.<br>* Other names: Triptans;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change efficacy (Pain free at two hours ) | Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan. | From baseline to 4 months | 
| Change efficacy (Pain free at two hours ) | Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan. | From baseline to 7 months | 
| Satisfaction (Likert scale 1-5) | Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA | From baseline to 4 months | 
| Satisfaction (Likert scale 1-5) | Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA | From baseline to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free at one hour | Percentage of patients who are completely free of pain after one hour of ingestion of their usual triptan. | 4 and 7 months | 
| Sustained pain-free | Percentage of patients who achieve pain-free at two hours and do not require rescue medication within 24-48 hours. | 4 and 7 months | 
| Headache relapse | Percentage of patients experiencing recurrence of pain within 48 h on triptans with long half-life or 24 h on triptans with short half-life. | 4 and 7 months |