MigrainePhase 3MAMNCT01035983
Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches
A Phase 3 study testing Frovatriptan 2.5 mg in people with Migraine, run by Endo USA Inc., a Keenova Therapeutics Company at 5 sites in 5 countries.
Trial summary
In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. 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 2.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Dec 2003to Jun 2005
- 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
- Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with at least a 12 month documented history of experiencing migraine according to IHS criteria, including confirmation of a 3 month diary based documented history of MAM.
- An average frequency of MAM in at least two out of three menstrual cycles, within the previous 12 months
- Regular, predictable menstrual periods
- MAM headaches occurring between Day -2 and day +4 of menses
- Able and willing to sign informed consent and to comply with study procedures, including completion of the diary cards.
Who cannot join
- More than three migraine attacks per month that were not MAM attacks
- A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral vascular disease
- Significant cerebrovascular disease including basilar or hemiplegic migraine
- Uncontrolled hypertension (SBP >180 mmHg, DBP >95 mmHg)
- Severe hepatic or renal insufficiency
- More than 15 headache days per month, exclusive of migraine headache
Show all 13Show fewer
- Any other condition or serious illness which, in the opinion of the investigator, would interfere with optimal participation in the study
- A history of clinically relevant allergy, including that to frovatriptan or other triptans
- Pregnant or breast-feeding, or intending to become pregnant or breast-feed during the study period (patients were to be using adequate contraception and have a negative pregnancy test at screening)
- Treatment with another investigational drug within 30 days or 5 half-lives (whichever was longer) before the screening visit
- Any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipation of any change during study participation
- Any change in the type or dose of any prophylactic migraine medication in the 2 months prior to screening, or anticipation of any change during study participation
- A history of migraine with aura, according to IHS criteria, and currently treated with a combined oral contraceptive (South Africa only).
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: An Open Label Study to Assess the Safety, Tolerability and Efficacy of Frovatriptan in the Prevention of Menstrually Associated Migraine (MAM) Headaches.
In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients were to visit the study site a total of 6 times. Efficacy and/or safety assessments were performed at each visit.
Read the detailed description
This Phase IIIb, open label, multi-centre study evaluated the safety and tolerability of frovatriptan taken by patients for up to 12 perimenstrual periods (PMPs) for the prevention of menstrual migraine (MM). The study required approximately 300 patients to treat 6 PMPs and 100 patients to treat 12 PMPs. To achieve these numbers, 550 patients were to be enrolled into the study. Once enrolled, patients were requested to treat at least 6 PMPs in the first 9 months and 12 PMPs overall. Patients were to remain in the study for a maximum of 15 months or until they had completed the treatment of 12 PMPs, whichever occurred sooner.Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6.
- Conditions
- Migraine
- Being tested
- Frovatriptan 2.5 mg
- Keywords
- menstrually associated migraine (MAM), Migraines,Menstrual Migraines, menstrually related migraines
- Medical subject headings
- Migraine Disorders, Limb-girdle muscular dystrophy, type 2C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frovatriptan 2.5 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Frovatriptan 2.5 mg | Experimental | Frovatriptan 2.5 mg tablets administered orally 2 x 2.5 mg twice daily (loading dose) on day 1, followed by 2.5 mg twice daily days 2 to 6. Receives: Drug: Frovatriptan 2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all treatment-emergent adverse events (AEs).
Measured: 9-15 months
Secondary outcomes (10)
Incidence of menstrual migraine headache
Measured: 9-15 months
Maximum headache severity
Measured: 9-15 months
Number of headache-free days during a treated perimenstrual period (PMP)
Measured: 9-15 months
Occurrence and severity of menstrual migraine headache-associated symptoms
Measured: 9-15 months
Maximum functional impairment during menstrual migraine headache
Measured: 9-15 months
Incidence and severity of intercurrent migraine
Measured: 9-15 months
Total migraine burden
Measured: 9-15 months
Standard hematology and biochemistry
Measured: 9-15 months
12-lead electrocardiogram (ECG) and vital signs, physical examination
Measured: 9-15 months
Short-form 12 (SF-12) Health Related Quality of Life Questionnaire
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2003
- Primary completionJun 2005
- Study completionJun 2005
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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 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
- Anne MacGregor, DIPM MFFP, Principal investigator, City of London Migraine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035983
- Sponsor's protocol ID
- VML 251-3MAM03
- Acronym
- MAM
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2009
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
MacGregor EA, Brandes JL, Silberstein S, Jeka S, Czapinski P, Shaw B, Pawsey S. Safety and tolerability of short-term preventive frovatriptan: a combined analysis. Headache. 2009 Oct;49(9):1298-314. doi: 10.1111/j.1526-4610.2009.01513.x.
PubMed 19788471
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
- An Open Label Study to Assess the Safety, Tolerability and Efficacy of Frovatriptan in the Prevention of Menstrually Associated Migraine (MAM) Headaches.
- ClinicalTrials.gov ID
- NCT01035983
- Acronym / sponsor ID
- MAM / VML 251-3MAM03
- Conditions
- Migraine
- Keywords
- menstrually associated migraine (MAM), Migraines,Menstrual Migraines, menstrually related migraines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Vernalis (R&D) Ltd
- Study start
- Dec 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 21 Dec 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.
In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients were to visit the study site a total of 6 times. Efficacy and/or safety assessments were performed at each visit.
Detailed description
This Phase IIIb, open label, multi-centre study evaluated the safety and tolerability of frovatriptan taken by patients for up to 12 perimenstrual periods (PMPs) for the prevention of menstrual migraine (MM). The study required approximately 300 patients to treat 6 PMPs and 100 patients to treat 12 PMPs. To achieve these numbers, 550 patients were to be enrolled into the study. Once enrolled, patients were requested to treat at least 6 PMPs in the first 9 months and 12 PMPs overall. Patients were to remain in the study for a maximum of 15 months or until they had completed the treatment of 12 PMPs, whichever occurred sooner.Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frovatriptan 2.5 mg | Experimental | Drug: Frovatriptan 2.5 mgFrovatriptan 2.5 mg tablets administered orally 2 x 2.5 mg twice daily (loading dose) on day 1, followed by 2.5 mg twice daily days 2 to 6. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with at least a 12 month documented history of experiencing migraine according to IHS criteria, including confirmation of a 3 month diary based documented history of MAM.
- An average frequency of MAM in at least two out of three menstrual cycles, within the previous 12 months
- Regular, predictable menstrual periods
- MAM headaches occurring between Day -2 and day +4 of menses
- Able and willing to sign informed consent and to comply with study procedures, including completion of the diary cards.
Key exclusion criteria (13 listed)
- More than three migraine attacks per month that were not MAM attacks
- A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral vascular disease
- Significant cerebrovascular disease including basilar or hemiplegic migraine
- Uncontrolled hypertension (SBP >180 mmHg, DBP >95 mmHg)
- 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 |
|---|---|---|
| Frovatriptan 2.5 mg | Drug | Frovatriptan 2.5 mg |
Primary outcome
Incidence of all treatment-emergent adverse events (AEs).
Time frame: 9-15 months
10 secondary outcomes
Incidence of menstrual migraine headache
Time frame: 9-15 months
Maximum headache severity
Time frame: 9-15 months
Number of headache-free days during a treated perimenstrual period (PMP)
Time frame: 9-15 months
Occurrence and severity of menstrual migraine headache-associated symptoms
Time frame: 9-15 months
Maximum functional impairment during menstrual migraine headache
Time frame: 9-15 months
Incidence and severity of intercurrent migraine
Time frame: 9-15 months
Total migraine burden
Time frame: 9-15 months
Standard hematology and biochemistry
Time frame: 9-15 months
12-lead electrocardiogram (ECG) and vital signs, physical examination
Time frame: 9-15 months
Short-form 12 (SF-12) Health Related Quality of Life Questionnaire
Time frame: 9-12 months
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.
- Results publication: PubMed 19788471MacGregor EA, Brandes JL, Silberstein S, Jeka S, Czapinski P, Shaw B, Pawsey S. Safety and tolerability of short-term preventive frovatriptan: a combined analysis. Headache. 2009 Oct;49(9):1298-314. doi: 10.1111/j.1526-4610.2009.01513.x.
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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.
Anne MacGregor, DIPM MFFP principal investigator
City of London Migraine Clinic
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Frovatriptan 2.5 mg in people with Migraine, run by Endo USA Inc., a Keenova Therapeutics Company at 5 sites in 5 countries.
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 5 inclusion and 13 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 5 sites in Germany, Hungary, Poland, South Africa, United Kingdom. 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 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 all treatment-emergent adverse events (AEs). (time frame: 9-15 months). 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 NCT01035983, 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.