Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499116
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-01
Brief Title:
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care a Pragmatic Clinical Trial PREMI Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
PREMI
Brief Summary:
This study which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine amitriptyline flunarizine topiramate and propranolol is a multicentre pragmatic parallel group open randomised trial Adults 18 candidates for preventive treatment for migraine those with a frequency of 4 monthly migraine days and who agree to participate in the clinical trial will be randomised to one of the 4 groups Sample 460 patients The primary outcome will be the reduction in monthly migraine days comparing amitriptyline flunarizine and topiramate with propranolol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-513597-22-00 | CTIS | None | None |