Migraine With or Without AuraPhase 3NCT01978496
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
A Phase 3 study testing Eletriptan 20 mg, Eletriptan 40 mg and Eletriptan 80 mg in people with Migraine With or Without Aura, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Migraine With or Without Aura
- What is being tested?
- Eletriptan 20 mg, Eletriptan 40 mg and Eletriptan 80 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,334 participants
- Where
- No sites listed yet
- Study dates
- Jul 1996to Dec 1997
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
- Capable of taking study medication as outpatients and recording its effects.
Who cannot join
- Pregnant or breast-feeding women
- Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average
- Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.
About this study
Official title: A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine
To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.
- Conditions
- Migraine With or Without Aura
- Being tested
- Placebo, Eletriptan 20 mg, Eletriptan 40 mg, Eletriptan 80 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
matching placebo
Eletriptan 20 mgDrug
20mg oral
Eletriptan 40 mgDrug
40mg oral
Eletriptan 80 mgDrug
80mg oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Eletriptan 20 mg | Experimental | Not described Receives: Drug: Eletriptan 20 mg |
| Eletriptan 40 mg | Experimental | Not described Receives: Drug: Eletriptan 40 mg |
| Eletriptan 80 mg | Experimental | Not described Receives: Drug: Eletriptan 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache responder rate at two hours after the first dose for the first attack.
A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.
Measured: 2 hours
Secondary outcomes (1)
Pain free responder rate at two hours after the first dose for the first attack.
Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startJul 1996
- Primary completionDec 1997
- Study completionDec 1997
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
- 1,334 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
- NCT01978496
- Sponsor's protocol ID
- A160-102
- Status last verified
- Jan 2021
- First submitted
- 31 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, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine
- ClinicalTrials.gov ID
- NCT01978496
- Acronym / sponsor ID
- A160-102
- Conditions
- Migraine With or Without Aura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,334 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 1996
- Primary completion
- Dec 1997 (actual)
- Study completion
- Dec 1997 (actual)
- First posted
- 7 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.
To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Eletriptan 20 mg | Experimental | Drug: Eletriptan 20 mg |
| Eletriptan 40 mg | Experimental | Drug: Eletriptan 40 mg |
| Eletriptan 80 mg | Experimental | Drug: Eletriptan 80 mg |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
- Capable of taking study medication as outpatients and recording its effects.
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding women
- Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average
- Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.
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 20 mg20mg oral | Drug | Eletriptan 20 mg |
| Eletriptan 40 mg40mg oral | Drug | Eletriptan 40 mg |
| Eletriptan 80 mg80mg oral | Drug | Eletriptan 80 mg |
Primary outcome
Headache responder rate at two hours after the first dose for the first attack.
Time frame: 2 hours
A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.
1 secondary outcome
Pain free responder rate at two hours after the first dose for the first attack.
Time frame: 2 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.
Related trials for Migraine With or Without Aura
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
RecruitingPhase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Acute Treatment of Migraine
RecruitingPhase 1
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
Migraine, Migraine Disease
RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
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 20 mg, Eletriptan 40 mg and Eletriptan 80 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 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 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 responder rate at two hours after the first dose for the first attack. (time frame: 2 hours). 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.