MigrainePhase 4NCT00259649
Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
A Phase 4 study testing eletriptan in people with Migraine, run by University of Pittsburgh at 1 site in United States.
Trial summary
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- eletriptan
- Type of treatment
- Pill or oral medicine
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-45 healthy menstruating female
Who cannot join
- cardiac or other conditions precluding use of eletriptan
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Assessment and Prevention of Menstrual Migraine: Phase 1-prospective Survey of Self-identified Menstrual Migraine. Phase 2-prevention of Menstrual Migraine With Relpax
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Read the detailed description
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
- Conditions
- Migraine
- Being tested
- eletriptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eletriptanDrug
Also called Relpax
oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Headache Index Score Among Patients
Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy
Measured: baseline to approximately three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startAug 2004
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Dawn Marcus, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259649
- Sponsor's protocol ID
- 901423
- Status last verified
- Jun 2011
- First submitted
- 26 Nov 2005
- Last updated
- 4 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Prevention of Menstrual Migraine: Phase 1-prospective Survey of Self-identified Menstrual Migraine. Phase 2-prevention of Menstrual Migraine With Relpax
- ClinicalTrials.gov ID
- NCT00259649
- Acronym / sponsor ID
- 901423
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2004
- Primary completion
- Aug 2008 (actual)
- First posted
- 29 Nov 2005 (estimated)
- Results
- Posted 4 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Detailed description
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-45 healthy menstruating female
Key exclusion criteria (1 listed)
- cardiac or other conditions precluding use of eletriptan
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 |
|---|---|---|
| eletriptanAlso: Relpaxoral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days | Drug | – |
Primary outcome
Change in Mean Headache Index Score Among Patients
Time frame: baseline to approximately three months
Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dawn Marcus, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing eletriptan in people with Migraine, run by University of Pittsburgh 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 1 inclusion and 1 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 4 Jul 2011. 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. 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?
Yes. Results are posted in the registry (first posted 4 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Headache Index Score Among Patients (time frame: baseline to approximately three months). 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 4 Jul 2011.