NCT01035983

Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches

An Open Label Study to Assess the Safety, Tolerability and Efficacy of Frovatriptan in the Prevention of Menstrually Associated Migraine (MAM) Headaches.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase IIIb, open label, multi-centre study evaluated the safety and tolerability of frovatriptan taken by patients for up to 12 perimenstrual periods (PMPs) for the prevention of menstrual migraine (MM). The study required approximately 300 patients to treat 6 PMPs and 100 patients to treat 12 PMPs. To achieve these numbers, 550 patients were to be enrolled into the study. Once enrolled, patients were requested to treat at least 6 PMPs in the first 9 months and 12 PMPs overall. Patients were to remain in the study for a maximum of 15 months or until they had completed the treatment of 12 PMPs, whichever occurred sooner.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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Frovatriptan 2.5 mg

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2009-12-21
• Last updated: 2024-01-02

Locations

5 sites across 5 countries: Germany, Hungary, Poland, South Africa, United Kingdom