Menstrually Associated MigrainePhase 3NCT00644033
A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
A Phase 3 study testing Frovatriptan in people with Menstrually Associated Migraine, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.
Trial summary
The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menstrually Associated Migraine
- What is being tested?
- Frovatriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 579 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Jun 2002
- Phase
- Phase 3
- 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
- Females aged 18 years and over
- 12 month or more documented history of menstrual migraine headache, according to International Headache Society classification
- An average frequency of MAM attacks in at lease 3 out of 4 menstrual cycles
- Regular predictable menstrual periods
- Able to accurately predict the onset of MAM headaches occurring between Day -2 and Day +4 of menses
- Able and willing to sign informed consent to comply with study procedures, including completion of diary cards
Who cannot join
- More than three migraine attacks per month that were not MAM attacks
- Coronary artery disease including coronary vasospasm
- Significant cerebrovascular disease including basilar or hemiplegic migraine
- Uncontrolled hypertension
- Severe hepatic or renal insufficiency
- More than 15 headache days per month
Show all 11Show fewer
- Any other condition or serious illness which would interfere with optimal participation in the study
- History of clinically relevant allergy, including that to frovatriptan or other triptans
- Pregnant or breast feeding or intending to become pregnant or to breast-feed during study period
- Participated in other frovatriptan menstrual migraine prevention studies
- Use of another investigation drug within 30 days or 5 half-lives (whichever is longer) before the screening visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Endo Pharmaceuticals
Chadds Ford, Pennsylvania, 19317
About this study
The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study, patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated onset of a MAM headache.
A statistically significant reduction in the incidence of MAM headache (p<0.0001) was observed with both dosing regimens of frovatriptan when compared to placebo. Additionally, the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of MAM headache (p<0.001). Significant reductions in MAM headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.
- Conditions
- Menstrually Associated Migraine
- Being tested
- Frovatriptan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrovatriptanDrug
2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
FrovatriptanDrug
2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
PlaceboDrug
placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Frovatriptan |
| 2 | Active comparator | Not described Receives: Drug: Frovatriptan |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of menstrually associated migraine (MAM) headache in the treated peri-menstrual period (PMP)
Secondary outcomes (14)
Incidence of moderate or severe MAM headaches
Incidence of severe MAM headaches
Duration of MAM headaches
Maximum headache intensity
Incidence of MAM headache associated symptoms and characteristics
Duration of MAM headache associated symptoms
Maximum functional impairment score during MAM headache
Incidence of moderate or severe functional impairment during MAM headache
Duration of moderate or severe functional impairment during MAM headache
Incidence of use of rescue medication for the treatment of a MAM headache
Patient satisfaction score at the end of each 6 day treated PMP
Adverse events
Standard hematology and biochemistry
12-lead ECGs, physical exam, vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJun 2001
- Primary completionJun 2002
- Study completionJun 2002
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 Menstrually Associated MigraineStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vernalis (R&D) Ltd
- Investigators
- Arthur Elkind, MD, Principal investigator, Elkind Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644033
- Sponsor's protocol ID
- VML 251 00/02
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2008
- Last updated
- 2 Jan 2024
- Results posted
- No
Publications
Silberstein SD, Berner T, Tobin J, Xiang Q, Campbell JC. Scheduled short-term prevention with frovatriptan for migraine occurring exclusively in association with menstruation. Headache. 2009 Oct;49(9):1283-97. doi: 10.1111/j.1526-4610.2009.01509.x. Epub 2009 Sep 14.
PubMed 19751371
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
- ClinicalTrials.gov ID
- NCT00644033
- Acronym / sponsor ID
- VML 251 00/02
- Conditions
- Menstrually Associated Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Vernalis (R&D) Ltd
- Study start
- Jun 2001
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 26 Mar 2008 (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.
The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study, patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated onset of a MAM headache.
A statistically significant reduction in the incidence of MAM headache (p<0.0001) was observed with both dosing regimens of frovatriptan when compared to placebo. Additionally, the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of MAM headache (p<0.001). Significant reductions in MAM headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Frovatriptan |
| 2 | Active comparator | Drug: Frovatriptan |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females aged 18 years and over
- 12 month or more documented history of menstrual migraine headache, according to International Headache Society classification
- An average frequency of MAM attacks in at lease 3 out of 4 menstrual cycles
- Regular predictable menstrual periods
- Able to accurately predict the onset of MAM headaches occurring between Day -2 and Day +4 of menses
Key exclusion criteria (11 listed)
- More than three migraine attacks per month that were not MAM attacks
- Coronary artery disease including coronary vasospasm
- Significant cerebrovascular disease including basilar or hemiplegic migraine
- Uncontrolled hypertension
- Severe hepatic or renal insufficiency
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 |
|---|---|---|
| Frovatriptan2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache | Drug | 1 |
| Frovatriptan2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache. | Drug | 2 |
| Placeboplacebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache. | Drug | 3 |
Primary outcome
Incidence of menstrually associated migraine (MAM) headache in the treated peri-menstrual period (PMP)
14 secondary outcomes
Incidence of moderate or severe MAM headaches
Incidence of severe MAM headaches
Duration of MAM headaches
Maximum headache intensity
Incidence of MAM headache associated symptoms and characteristics
Duration of MAM headache associated symptoms
Maximum functional impairment score during MAM headache
Incidence of moderate or severe functional impairment during MAM headache
Duration of moderate or severe functional impairment during MAM headache
Incidence of use of rescue medication for the treatment of a MAM headache
Patient satisfaction score at the end of each 6 day treated PMP
Adverse events
Standard hematology and biochemistry
12-lead ECGs, physical exam, vital signs
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 2 Jan 2024.
- Derived from this study: PubMed 19751371Silberstein SD, Berner T, Tobin J, Xiang Q, Campbell JC. Scheduled short-term prevention with frovatriptan for migraine occurring exclusively in association with menstruation. Headache. 2009 Oct;49(9):1283-97. doi: 10.1111/j.1526-4610.2009.01509.x. Epub 2009 Sep 14.
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.
Arthur Elkind, MD principal investigator
Elkind Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Frovatriptan in people with Menstrually Associated Migraine, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site 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 6 inclusion and 11 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of menstrually associated migraine (MAM) headache in the treated peri-menstrual period (PMP). 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 NCT00644033, 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 2 Jan 2024.