Migraine With or Without AuraPhase 3NCT01986088
Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
A Phase 3 study testing Eletriptan 40 mg, Eletriptan 80 mg and Sumatriptan 50 mg in people with Migraine With or Without Aura, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Migraine With or Without Aura
- What is being tested?
- Eletriptan 40 mg, Eletriptan 80 mg and Sumatriptan 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,008 participants
- Where
- No sites listed yet
- Study dates
- Nov 1996to Jan 1998
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
- Patients had to be capable of taking study medication as outpatients and recording the effects.
Who cannot join
- Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
- Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.
About this study
Official title: A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).
A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.
- Conditions
- Migraine With or Without Aura
- Being tested
- Placebo, Eletriptan 40 mg, Eletriptan 80 mg, Sumatriptan 50 mg, Sumatriptan 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
matching placebo
Eletriptan 40 mgDrug
40mg oral
Eletriptan 80 mgDrug
80mg oral
Sumatriptan 50 mgDrug
50mg oral
Sumatriptan 100 mgDrug
100mg oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Eletriptan 40 mg | Experimental | Not described Receives: Drug: Eletriptan 40 mg |
| Eletriptan 80 mg | Experimental | Not described Receives: Drug: Eletriptan 80 mg |
| Sumatriptan 50 mg | Experimental | Not described Receives: Drug: Sumatriptan 50 mg |
| Sumatriptan 100 mg | Experimental | Not described Receives: Drug: Sumatriptan 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache response at 1 hour after treatment of the first attack.
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
Measured: 1 hour
Secondary outcomes (4)
Headache severity
Measured: .5, 1, 2, 4 and 24 hours
Pain-free response
Measured: .5, 1, 2, 4 and 24 hours
Functional response
Measured: .5, 1, 2, 4 and 24 hours
Presence or absence of nausea, photophobia, and phonophobia
Measured: .5, 1, 2, 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 posted18 Nov 2013 (estimated)
- Study startNov 1996
- Primary completionJan 1998
- Study completionJan 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With or Without AuraStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986088
- Sponsor's protocol ID
- A160-318
- Status last verified
- Jan 2021
- First submitted
- 11 Nov 2013
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).
- ClinicalTrials.gov ID
- NCT01986088
- Acronym / sponsor ID
- A160-318
- Conditions
- Migraine With or Without Aura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 1996
- Primary completion
- Jan 1998 (actual)
- Study completion
- Jan 1998 (actual)
- First posted
- 18 Nov 2013 (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.
A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Eletriptan 40 mg | Experimental | Drug: Eletriptan 40 mg |
| Eletriptan 80 mg | Experimental | Drug: Eletriptan 80 mg |
| Sumatriptan 50 mg | Experimental | Drug: Sumatriptan 50 mg |
| Sumatriptan 100 mg | Experimental | Drug: Sumatriptan 100 mg |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
- Patients had to be capable of taking study medication as outpatients and recording the effects.
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
- Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.
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 |
|---|---|---|
| Placebomatching placebo | Drug | Placebo |
| Eletriptan 40 mg40mg oral | Drug | Eletriptan 40 mg |
| Eletriptan 80 mg80mg oral | Drug | Eletriptan 80 mg |
| Sumatriptan 50 mg50mg oral | Drug | Sumatriptan 50 mg |
| Sumatriptan 100 mg100mg oral | Drug | Sumatriptan 100 mg |
Primary outcome
Headache response at 1 hour after treatment of the first attack.
Time frame: 1 hour
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
4 secondary outcomes
Headache severity
Time frame: .5, 1, 2, 4 and 24 hours
Pain-free response
Time frame: .5, 1, 2, 4 and 24 hours
Functional response
Time frame: .5, 1, 2, 4 and 24 hours
Presence or absence of nausea, photophobia, and phonophobia
Time frame: .5, 1, 2, 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 28 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eletriptan 40 mg, Eletriptan 80 mg and Sumatriptan 50 mg in people with Migraine With or Without Aura, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 2 inclusion and 2 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 28 Jan 2021. 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. 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?
Headache response at 1 hour after treatment of the first attack. (time frame: 1 hour). 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 28 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.