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

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871152
• Other study ID #: IIBSP-TOX-2020-67
• Status: Recruiting
• Start date: March 25, 2021
• Est. completion date: September 25, 2022

Study information

• Verified date: October 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Robert Belvís, PhD
• Phone: +34 93 291 90 00
• Email: rbelvis[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 25, 2022
• Est. primary completion date: September 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• OnabotulinumtoxinA
To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.

Locations

Country	Name	City	State
Spain	Headache and Neuralgia Unit. Neurology Department. Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Satisfaction (Likert scale 1-5)	Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA	From baseline to 4 months
Primary	Satisfaction (Likert scale 1-5)	Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA	From baseline to 7 months
Secondary	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
Secondary	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
Secondary	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