MigrainePhase 3NCT00475514
A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine
A Phase 3 study testing Frovatriptan 2.5mg QD and Frovatriptan 2.5 mg BID in people with Migraine, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Frovatriptan 2.5mg QD and Frovatriptan 2.5 mg BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Mar 2006
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'
Who cannot join
None listed.
About this study
Official title: A Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-related Migraine (MRM) Headaches in a 'Difficult to Treat' Population
Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.
Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.
Read the detailed description
See above
- Conditions
- Migraine
- Being tested
- Frovatriptan 2.5mg QD, Frovatriptan 2.5 mg BID, placebo
- Keywords
- Menstrually-related Migraine Headache, 'Difficult to Treat' as specified in protocol
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frovatriptan 2.5mg QDDrug
Frovatriptan 2.5 mg BIDDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
Secondary outcomes (8)
Incidence of MRM headache
Maximum headache intensity
Incidence of moderate or severe MRM headaches
Number of MRM headache free days during treated PMPs
Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)
Functional impairment during treatment phase
Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startOct 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475514
- Sponsor's protocol ID
- VML 251-3MRM02
- Status last verified
- Dec 2023
- First submitted
- 16 May 2007
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
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 Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-related Migraine (MRM) Headaches in a 'Difficult to Treat' Population
- ClinicalTrials.gov ID
- NCT00475514
- Acronym / sponsor ID
- VML 251-3MRM02
- Conditions
- Migraine
- Keywords
- Menstrually-related Migraine Headache, 'Difficult to Treat' as specified in protocol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 21 May 2007 (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.
Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.
Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.
Detailed description
See above
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Frovatriptan 2.5mg QD | Drug | – |
| Frovatriptan 2.5 mg BID | Drug | – |
| placebo | Drug | – |
Primary outcome
Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
8 secondary outcomes
Incidence of MRM headache
Maximum headache intensity
Incidence of moderate or severe MRM headaches
Number of MRM headache free days during treated PMPs
Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)
Functional impairment during treatment phase
Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Frovatriptan 2.5mg QD and Frovatriptan 2.5 mg BID in people with Migraine, run by Endo USA Inc., a Keenova Therapeutics Company.
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 1 inclusion and 0 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.
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 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?
Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 7 Nov 2026.