Migraine With or Without AuraPhase 3NCT01989936
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
A Phase 3 study testing 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. at 43 sites in 6 countries.
Trial summary
To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial). Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Migraine With or Without Aura
- What is being tested?
- Eletriptan 40 mg and Eletriptan 80 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 43 sitesin 6 countries
- Study dates
- Jan 1999to Sep 2000
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
- Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
- Female subjects required to be adequately protected against pregnancy.
Who cannot join
- pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension.
- Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination
- Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical.
- Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.
Trial locations and contacts
43 sites in 6 countries.
43 sites in 6 countries
Location not given15 sites
Danderydssjukhus
Foretagshalsovarden Linden
Fylkessjukehuset I Molde
Huslakargruppen
Lakarhuset Hermelinen
Lakarhuset
Limhamns Lakargrupp, Tarnan
Lundsbysjukhus
Medicinskt Centrum
Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina
Primarvarden
Regionsykehuset I Trondheim
Sentralsjukehuset I Hedmark
Sint Anna Ziekenhuis
Vardcentralen
Denmark8 sites
Arhus Kommunehospital
Arhus C, 8000
Bispebjerg Hospital
Copenhagen, 2400
Centralsygehuset I Esbjerg
Esbjerg, 6700
Kas Glostrup
Glostrup Municipality, 2600
Hilleroed Sygehus
Hilleroed, 3400
Knud Kjaersgaard Pedersen
Hjørring, 9800
Neubauer, Ole (Private Practice)
Nykoebing F, 4800
Korsgaard, Anne G. (Private Practice)
Odense C, 5000
Finland7 sites
Haukiputaan Laakarikeskus
Haukipudas, 90830
Helsinki University Central Hospital
Helsinki, 00290
Hyvinkaa District Hospital
Hyvinkää, 05850
Torikeskuksen Laakariasema
Jyväskylä, 40100
Mikkelin Paansarkypoliklinikka (Mikkeli Headache)
Mikkeli, 50100
Porin Laakarikeskus
Pori, 28100
Turku Headache Centre
Turku, 20110
Sweden7 sites
Migranklinik-Goeteborg
Gothenburg, SE-411 17
Neurologsektionen, Lasarettet
Helsingborg, 251 87
Neuro Kliniken, Helsingborg
Helsingborg, 25221
Medicin Kliniken, Sjukhuset
Kristinehamn, 681 80
Medicin Kliniken, Universitetssjukhuset
Lund, 22185
St Gorans Sjukhus
Stockholm, SE-112 81
Kronobergskliniken
Vaxjo, SE-352 34
Norway4 sites
Sentralsykehuset I Akershus
Nordbyhagen, 1474
Private Practice, Oyvind Rosjo
Oslo, 0166
Volvat Medisinske Senter
Oslo, 0303
Strandquist, Dr. Stein Bror
Tønsberg, 3111
Netherlands2 sites
Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
's-Hertogenbosch, 5223GV
Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
Amsterdam, 1061 AE
About this study
Official title: A Multicenter, Double - Blind, Randomized, Placebo - Controlled Parallel Group Study of the Efficacy and Safety of Oral Eletriptan (40 and 80mg) Given for the Treatment of Acute Migraine in Subjects Discontinued From Oral Sumatriptan
To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).
- Conditions
- Migraine With or Without Aura
- Being tested
- Placebo, 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
Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
Eletriptan 40 mgDrug
Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
Eletriptan 80 mgDrug
Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack
Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication
Measured: 18 weeks
Secondary outcomes (1)
Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed
Recurrence was defined as a return of headache to moderate or severe intensity within 2-24 h if the subject had an initial response within 2 h of taking the study medication.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 1999
- Primary completionSep 2000
- Study completionSep 2000
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
- 446 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
- NCT01989936
- Sponsor's protocol ID
- A1601006
- Status last verified
- Jan 2021
- First submitted
- 30 Oct 2013
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
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 Multicenter, Double - Blind, Randomized, Placebo - Controlled Parallel Group Study of the Efficacy and Safety of Oral Eletriptan (40 and 80mg) Given for the Treatment of Acute Migraine in Subjects Discontinued From Oral Sumatriptan
- ClinicalTrials.gov ID
- NCT01989936
- Acronym / sponsor ID
- A1601006
- Conditions
- Migraine With or Without Aura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Sep 2000 (actual)
- Study completion
- Sep 2000 (actual)
- First posted
- 21 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 determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Eletriptan 40 mg | Experimental | Drug: Eletriptan 40 mg |
| Eletriptan 80 mg | Experimental | Drug: Eletriptan 80 mg |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
- Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
- Female subjects required to be adequately protected against pregnancy.
Key exclusion criteria (4 listed)
- pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension.
- Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination
- Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical.
- Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.
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 |
|---|---|---|
| PlaceboSubjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset. | Drug | Placebo |
| Eletriptan 40 mgSubjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset. | Drug | Eletriptan 40 mg |
| Eletriptan 80 mgSubjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset. | Drug | Eletriptan 80 mg |
Primary outcome
The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack
Time frame: 18 weeks
Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication
1 secondary outcome
Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed
Time frame: 18 weeks
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
43 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 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. at 43 sites in 6 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 4 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 43 sites in Denmark, Finland, Sweden, Norway, Netherlands. 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. 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?
The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack (time frame: 18 weeks). 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.