drugset / Trial / NCT06499116
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
Phase 4
Not yet recruiting
460 enrolled
Jordi Gol Institute for Primary Care Research
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · collabInstitut Català de la Salut · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2024-10
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amitriptyline | Small molecule | 10 mg | Oral |
| Subject | Amitriptyline | Small molecule | 75 mg | Oral |
| Subject | Flunarizine | Small molecule | 2.5 mg | Oral |
| Subject | Flunarizine | Small molecule | 10 mg | Oral |
| Comparator | Propranolol | Small molecule | 20 mg | Oral |
| Comparator | Propranolol | Small molecule | 120 mg | Oral |
| Subject | Topiramate | Small molecule | 25 mg | Oral |
| Subject | Topiramate | Small molecule | 100 mg | Oral |