Menstrual Migraine (MM) HeadachesPhase 4NCT00904098
Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
A Phase 4 study testing Frovatriptan in people with Menstrual Migraine (MM) Headaches, run by Endo USA Inc., a Keenova Therapeutics Company at 21 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menstrual Migraine (MM) Headaches
- What is being tested?
- Frovatriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 21 sitesUnited States
- Study dates
- Sep 2005to Feb 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Blackwood, New Jersey
Study site
Burlington, North Carolina
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Largo, Florida
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Norristown, Pennsylvania
Study site
Philadelphia, Pennsylvania
Study site
Plainview, New York
Study site
Raleigh, North Carolina
Study site
Saint Petersburg, Pennsylvania
Study site
Salisbury, North Carolina
Study site
Stratford, Connecticut
Study site
Tampa, Florida
Study site
Upland, Pennsylvania
Study site
Vestal, New York
Study site
West Chester, Ohio
Study site
Winston-Salem, North Carolina
About this study
Official title: Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine
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.
- Conditions
- Menstrual Migraine (MM) Headaches
- Being tested
- Frovatriptan, Usual Care
- Keywords
- migraine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrovatriptanDrug
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 CareDrug
Current treatment used to treat all migraine headaches
| Study group | Role | What they receive |
|---|---|---|
| Frovatriptan | Experimental | Frovatriptan 2.5 mg oral tablet Receives: Drug: Frovatriptan |
| Usual Care | Active comparator | Usual care includes the current treatment used to treat all episodes of migraine headache Receives: Drug: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache pain severity
Measured: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startSep 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual Migraine (MM) HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sr. Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904098
- Sponsor's protocol ID
- EN3266-401
- Status last verified
- Feb 2010
- First submitted
- 15 May 2009
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20236340
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine
- ClinicalTrials.gov ID
- NCT00904098
- Acronym / sponsor ID
- EN3266-401
- Conditions
- Menstrual Migraine (MM) Headaches
- Keywords
- migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frovatriptan | Experimental | Drug: FrovatriptanFrovatriptan 2.5 mg oral tablet |
| Usual Care | Active comparator | Drug: Usual CareUsual care includes the current treatment used to treat all episodes of migraine headache |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FrovatriptanThis study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases: 1. 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) 2. 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. | Drug | Frovatriptan |
| Usual CareCurrent treatment used to treat all migraine headaches | Drug | Usual Care |
Primary outcome
Headache pain severity
Time frame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
- Derived from this study: PubMed 20236340MacGregor 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.
Related trials for Menstrual Migraine (MM) Headaches
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sr. Director study director
Endo USA Inc., a Keenova Therapeutics Company
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Frovatriptan in people with Menstrual Migraine (MM) Headaches, run by Endo USA Inc., a Keenova Therapeutics Company at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache pain severity (time frame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00904098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2010.