Migraine With or Without AuraPhase 3NCT01986270
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
A Phase 3 study testing Eletriptan 40 mg, Eletriptan 80 mg and Sumatriptan 25 mg in people with Migraine With or Without Aura, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With or Without Aura
- What is being tested?
- Eletriptan 40 mg, Eletriptan 80 mg and Sumatriptan 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,141 participants
- Where
- No sites listed yet
- Study dates
- Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
- Subjects capable of taking medication as outpatients, and recording the effects of such medication.
Who cannot join
- Pregnant or breast-feeding women
- Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.
About this study
Official title: A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine
The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.
- Conditions
- Migraine With or Without Aura
- Being tested
- Placebo, Eletriptan 40 mg, Eletriptan 80 mg, Sumatriptan 25 mg, Sumatriptan 50 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 25 mgDrug
25mg oral
Sumatriptan 50 mgDrug
50mg 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 25 mg | Experimental | Not described Receives: Drug: Sumatriptan 25 mg |
| Sumatriptan 50 mg | Experimental | Not described Receives: Drug: Sumatriptan 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache response at 1 hour after the first dose for 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 (1)
Pain-free response at 1 hour after the first dose for the first attack.
A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose.
Measured: 1 hour
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 startDec 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
- 1,141 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
- NCT01986270
- Sponsor's protocol ID
- A160-104
- Status last verified
- Jan 2021
- First submitted
- 30 Oct 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 Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT01986270
- Acronym / sponsor ID
- A160-104
- Conditions
- Migraine With or Without Aura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,141 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 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.
The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.
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 25 mg | Experimental | Drug: Sumatriptan 25 mg |
| Sumatriptan 50 mg | Experimental | Drug: Sumatriptan 50 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
- Subjects capable of taking medication as outpatients, and recording the effects of such medication.
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women
- Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.
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 25 mg25mg oral | Drug | Sumatriptan 25 mg |
| Sumatriptan 50 mg50mg oral | Drug | Sumatriptan 50 mg |
Primary outcome
Headache response at 1 hour after the first dose for 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.
1 secondary outcome
Pain-free response at 1 hour after the first dose for the first attack.
Time frame: 1 hour
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 25 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 the first dose for 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.