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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who meet criteria for chronic migraine and have failed 2 or more oral preventive treatments (including topiramate) or have a contraindication to taking topiramate.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Belvís, PhD | Contact | +34 93 291 90 00 | rbelvis@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Robert Belvís, PhD | Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Headache and Neuralgia Unit. Neurology Department. Hospital Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D014363 | Tryptamines |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |