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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Collaborator: Vernalis (R&D) Ltd
• Treatments: Frovatriptan

Criteria

Inclusion Criteria:

• Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with at least a 12 month documented history of experiencing migraine according to IHS criteria, including confirmation of a 3 month diary based documented history of MAM.

• An average frequency of MAM in at least two out of three menstrual cycles, within the previous 12 months

• Regular, predictable menstrual periods

• MAM headaches occurring between Day -2 and day +4 of menses

• Able and willing to sign informed consent and to comply with study procedures, including completion of the diary cards.

Exclusion Criteria:

• More than three migraine attacks per month that were not MAM attacks

• A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral vascular disease

• Significant cerebrovascular disease including basilar or hemiplegic migraine

• Uncontrolled hypertension (SBP >180 mmHg, DBP >95 mmHg)

• Severe hepatic or renal insufficiency

• More than 15 headache days per month, exclusive of migraine headache

• Any other condition or serious illness which, in the opinion of the investigator, would interfere with optimal participation in the study

• A history of clinically relevant allergy, including that to frovatriptan or other triptans

• Pregnant or breast-feeding, or intending to become pregnant or breast-feed during the study period (patients were to be using adequate contraception and have a negative pregnancy test at screening)

• Treatment with another investigational drug within 30 days or 5 half-lives (whichever was longer) before the screening visit

• Any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipation of any change during study participation

• Any change in the type or dose of any prophylactic migraine medication in the 2 months prior to screening, or anticipation of any change during study participation

• A history of migraine with aura, according to IHS criteria, and currently treated with a combined oral contraceptive (South Africa only).