Clinical trial NCT00904098: Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
Official title: Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menstrual Migraine (MM) Headaches
Keywords: migraine
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Headache pain severity
timeFrame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
Secondary outcomes:
measure: Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)
measure: Occurrence and severity of functional impairment during menstrual migraine
measure: Use of rescue medication and additional frovatriptan dose
measure: Patient satisfaction with treatment
measure: Patient preference of current vs. study treatment (end of study only)
measure: Safety as assessed by occurrence of AEs
Other outcomes:
Locations:
city: Stratford
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Blackwood
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Plainview
country: United States
state: New York
city: Vestal
country: United States
state: New York
city: Burlington
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: West Chester
country: United States
state: Ohio
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: St. Petersburg
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Endo Pharmaceuticals
name: Sr. Director
role: STUDY_DIRECTOR
References:
citation: MacGregor EA, Victor TW, Hu X, Xiang Q, Puenpatom RA, Chen W, Campbell JC. Characteristics of menstrual vs nonmenstrual migraine: a post hoc, within-woman analysis of the usual-care phase of a nonrandomized menstrual migraine clinical trial. Headache. 2010 Apr;50(4):528-38. doi: 10.1111/j.1526-4610.2010.01625.x. Epub 2010 Mar 2.