Back to resultsEffectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
Primary Purpose
Menstrual Migraine (MM) Headaches
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Frovatriptan
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Menstrual Migraine (MM) Headaches focused on measuring migraine
Eligibility Criteria
Inclusion Criteria:
- Had MM headaches occurring between Day -2 and Day +3 of menses
- Had at least one year history of MM headaches
- Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
- Had regular predictable menstrual periods (28 ± 4 days)
Exclusion Criteria:
- Had a history of more than 15 headache days per month
- As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
- 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
- Had significant cerebrovascular disease, including basilar or hemiplegic migraine
- Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg
- Had severe hepatic or renal insufficiency
- Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Frovatriptan
Usual Care
Arm Description
Frovatriptan 2.5 mg oral tablet
Usual care includes the current treatment used to treat all episodes of migraine headache
Outcomes
Primary Outcome Measures
Headache pain severity
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00904098
Brief Title
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
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Migraine (MM) Headaches
Keywords
migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Frovatriptan
Arm Type
Experimental
Arm Description
Frovatriptan 2.5 mg oral tablet
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care includes the current treatment used to treat all episodes of migraine headache
Intervention Type
Drug
Intervention Name(s)
Frovatriptan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Usual Care
Intervention Description
Current treatment used to treat all migraine headaches
Primary Outcome Measure Information:
Title
Headache pain severity
Time Frame
Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
Secondary Outcome Measure Information:
Title
Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)
Title
Occurrence and severity of functional impairment during menstrual migraine
Title
Use of rescue medication and additional frovatriptan dose
Title
Patient satisfaction with treatment
Title
Patient preference of current vs. study treatment (end of study only)
Title
Safety as assessed by occurrence of AEs
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Had MM headaches occurring between Day -2 and Day +3 of menses
Had at least one year history of MM headaches
Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
Had regular predictable menstrual periods (28 ± 4 days)
Exclusion Criteria:
Had a history of more than 15 headache days per month
As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
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
Had significant cerebrovascular disease, including basilar or hemiplegic migraine
Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg
Had severe hepatic or renal insufficiency
Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Director
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Stratford
State/Province
Connecticut
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Largo
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Blackwood
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Plainview
State/Province
New York
Country
United States
City
Vestal
State/Province
New York
Country
United States
City
Burlington
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Salisbury
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
West Chester
State/Province
Ohio
Country
United States
City
Norristown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
St. Petersburg
State/Province
Pennsylvania
Country
United States
City
Upland
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20236340
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.
Results Reference
derived
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Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
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