drugset / Trial / NCT01035983
Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches
Phase 3
Completed
550 enrolled
Endo USA Inc., a Keenova Therapeutics Company
Vernalis (R&D) Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients were to visit the study site a total of 6 times. Efficacy and/or safety assessments were performed at each visit.
Timeline
- Start
- 2003-12
- Primary completion
- 2005-06
- Completion
- 2005-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Frovatriptan | Small molecule | 2.5 mg | Oral |