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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Unknown

Conditions: Chronic Migraine

Treatments: Drug: OnabotulinumtoxinA

Study type: Observational

Funder types: Other

Identifiers

NCT04871152

IIBSP-TOX-2020-67

Details and patient eligibility

About

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.

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

100 participants in 1 patient group

Patients with chronic migraine

Description:

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.

Treatment:

Drug: OnabotulinumtoxinA