Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459648
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-05
Brief Title:
Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Organization:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Overview
Official Title:
Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
PREDI-CGRP
Brief Summary:
Being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs but above all in their quality of life With the present study the investigators aim to analyze in a combined way different clinical biological and neuroimaging variables which allow the clinical staff to anticipate the response to treatment with anti-CGRP monoclonal antibodies in patients with migraine
Detailed Description:
The study consists of an initial visit coinciding with the start of treatment a subsequent visit after 6 months of treatment and finally another after 12 months coinciding with the end of treatment In case of worsening after suspension a clinical visit will be carried out at the time of worsening to evaluate the reintroduction of the drug and in case of reintroduction a visit will be carried out after 3 months If patients do not worsen a visit will be made 6 months after completing treatment
At each visit demographic and clinical variables will be collected In addition 3 blood tests will be performed corresponding to the beginning of treatment after 6 months and a month and a half from the last infiltration Likewise a brain MRI will be obtained prior to the start of treatment These blood samples and neuroimaging data will be processed for subsequent analysis
At each visit demographic and clinical variables will be collected In addition 3 blood tests will be performed corresponding to the beginning of treatment after 6 months and a month and a half from the last infiltration Likewise a brain MRI will be obtained prior to the start of treatment These blood samples and neuroimaging data will be processed for subsequent analysis
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?:
False
Is an FDA AA801 Violation?:
None