Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine

Phase 4

Completed

• Conditions: Menstrual Migraine (MM) Headaches
• Interventions: Drug: Usual Care; Drug: Frovatriptan

• Registration Number: NCT00904098
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society \[IHS\] Grade 1) of MM compared with patients' current treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-12
• Last Update Posted: 2010-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

Inclusion Criteria

1. Had MM headaches occurring between Day -2 and Day +3 of menses
2. Had at least one year history of MM headaches
3. Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
4. Had regular predictable menstrual periods (28 ± 4 days)

Exclusion Criteria

1. Had a history of more than 15 headache days per month
2. As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
3. Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease
4. Had significant cerebrovascular disease, including basilar or hemiplegic migraine
5. Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg
6. Had severe hepatic or renal insufficiency
7. Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Usual care includes the current treatment used to treat all episodes of migraine headache
Frovatriptan	Frovatriptan	Frovatriptan 2.5 mg oral tablet

Primary Outcome Measures

Name	Time	Method
Headache pain severity	Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)

Secondary Outcome Measures

Name	Time	Method
Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)
Occurrence and severity of functional impairment during menstrual migraine
Use of rescue medication and additional frovatriptan dose
Patient satisfaction with treatment
Patient preference of current vs. study treatment (end of study only)
Safety as assessed by occurrence of AEs