Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871152
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-04-23
Brief Title:
Trip-Tox Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Trip-tox Study Analysis of the Efficacy and Satisfaction of Symptomatic Treatment With Triptans in Patients With Chronic Migraine Undergoing onabotulinumtoxinA Treatment
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n100 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 dÈtica de la Investigació amb Medicaments CEIm de lHospital de la Santa Creu i Sant Pau
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 n100 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 dÈtica de la Investigació amb Medicaments CEIm de lHospital de la Santa Creu i Sant Pau
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None