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

Menstrual Migraine (MM) Headaches Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904098
• Other study ID #: EN3266-401
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2009
• Last updated: February 12, 2010
• Start date: September 2005
• Est. completion date: February 2006

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menstrual Migraine (MM) Headaches
• Migraine Disorders

Intervention

Drug:
• Frovatriptan
This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases: A Usual Care phase (approximately 1 month in duration) included one menstrual period during which female patients treated all episodes of migraine headaches using their current treatment (referred to as the Baseline phase in the protocol) An Acute Treatment phase (approximately 1 month in duration), following the Usual Care phase, included one menstrual period during which female patients used frovatriptan 2.5 mg to treat all episodes of migraine headache when their headache reached IHS Grade 1. If needed, a second dose of frovatriptan 2.5 mg was administered; however, this second dose could not be administered within 2 hours of the initial dose (i.e., there must have been at least 2 hours between doses of frovatriptan). The total daily dose of frovatriptan was not to exceed 3 tablets over a 24-hour period.
• Usual Care
Current treatment used to treat all migraine headaches

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache pain severity		Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)	No
Secondary	Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)			No
Secondary	Occurrence and severity of functional impairment during menstrual migraine			No
Secondary	Use of rescue medication and additional frovatriptan dose			No
Secondary	Patient satisfaction with treatment			No
Secondary	Patient preference of current vs. study treatment (end of study only)			No
Secondary	Safety as assessed by occurrence of AEs			Yes