Clinical trial NCT04871152: Trip-Tox, Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine
Official title: Trip-tox Study. Analysis of the Efficacy and Satisfaction of Symptomatic Treatment With Triptans in Patients With Chronic Migraine Undergoing onabotulinumtoxinA Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Migraine
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change efficacy (Pain free at two hours )
timeFrame: From baseline to 4 months
measure: Change efficacy (Pain free at two hours )
timeFrame: From baseline to 7 months
measure: Satisfaction (Likert scale 1-5)
timeFrame: From baseline to 4 months
measure: Satisfaction (Likert scale 1-5)
timeFrame: From baseline to 7 months
Secondary outcomes:
measure: Pain free at one hour
timeFrame: 4 and 7 months
measure: Sustained pain-free
timeFrame: 4 and 7 months
measure: Headache relapse
timeFrame: 4 and 7 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Headache and Neuralgia Unit. Neurology Department. Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
name: Robert Belvís, PhD
role: PRINCIPAL_INVESTIGATOR
References: