MigrainePhase 4NCT00634985
Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
A Phase 4 study testing eletriptan in people with Migraine, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 6 sites in 2 countries.
Trial summary
To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- eletriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Nov 2002to Dec 2003
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Met International Headache Society diagnostic criteria for migraine with or without aura
- Expected to suffer one to six acute migraine attacks per month based on past history
- Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs
Who cannot join
- Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
- Atypical migraines that consistently failed to respond to adequate medical therapy
- Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Turkey (Türkiye)5 sites
Pfizer Investigational Site
Çapa, Istanbul
Pfizer Investigational Site
Gaziantep
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Izmir
Pfizer Investigational Site
Samsun
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS
To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)
- 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
40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: eletriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache severity and response post-treatment
Measured: 2 hours
Functional response post-treatment
Measured: 2 hours
Secondary outcomes (11)
Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
Measured: 1, 2, 4, and 24 hours
Migraine recurrence post-treatment
Measured: 1, 2, 4, and 24 hours
Time loss (from normal activities and from work) post-treatment
Measured: 24 hours
Subject preference and acceptability post-treatment
Measured: 24 hours and 12 weeks
Subject satisfaction post-treatment
Measured: 2 and 24 hours
Adverse events
Measured: Week 12
Physical examination
Measured: Week 12
Vital signs
Measured: Week 12
Electrocardiogram
Measured: Week 12
Headache severity and response at baseline and post-treatment
Measured: 1, 4 and 24 hours
Functional impairment severity and response at baseline and post-treatment
Measured: 1, 4 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startNov 2002
- Study completionDec 2003
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634985
- Sponsor's protocol ID
- A1601085
- Status last verified
- Jan 2021
- First submitted
- 3 Mar 2008
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS
- ClinicalTrials.gov ID
- NCT00634985
- Acronym / sponsor ID
- A1601085
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Dec 2003 (actual)
- First posted
- 13 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.
To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: eletriptan |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Met International Headache Society diagnostic criteria for migraine with or without aura
- Expected to suffer one to six acute migraine attacks per month based on past history
- Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs
Key exclusion criteria (3 listed)
- Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
- Atypical migraines that consistently failed to respond to adequate medical therapy
- Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura
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 |
|---|---|---|
| eletriptan40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response | Drug | A |
Primary outcome
Headache severity and response post-treatment
Time frame: 2 hours
Functional response post-treatment
Time frame: 2 hours
11 secondary outcomes
Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
Time frame: 1, 2, 4, and 24 hours
Migraine recurrence post-treatment
Time frame: 1, 2, 4, and 24 hours
Time loss (from normal activities and from work) post-treatment
Time frame: 24 hours
Subject preference and acceptability post-treatment
Time frame: 24 hours and 12 weeks
Subject satisfaction post-treatment
Time frame: 2 and 24 hours
Adverse events
Time frame: Week 12
Physical examination
Time frame: Week 12
Vital signs
Time frame: Week 12
Electrocardiogram
Time frame: Week 12
Headache severity and response at baseline and post-treatment
Time frame: 1, 4 and 24 hours
Functional impairment severity and response at baseline and post-treatment
Time frame: 1, 4 and 24 hours
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 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 2 countries: 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 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 6 sites in 2 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 3 inclusion and 3 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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 severity and response post-treatment (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 27 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.