MigrainePhase 4NCT00174395
A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
A Phase 4 study testing eletriptan in people with Migraine, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in Canada.
Trial summary
To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- eletriptan
- How many people
- 220 participants
- Where
- 33 sitesCanada
- Study dates
- Mar 2005to Oct 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of migraine with or without aura according to the recent IHS criteria.
- Migraine headaches must have been present for more than one year.
- History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.
Who cannot join
- Subjects with current or past history of coronary artery disease.
- Pregnant or breastfeeding women.
- Subjects who have chronic daily headaches.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Canada33 sites
Pfizer Investigational Site
Bathurst, New Brunswick
Pfizer Investigational Site
Bolton, Ontario
Pfizer Investigational Site
Brampton, Ontario
Pfizer Investigational Site
Chilliwack, British Columbia
Pfizer Investigational Site
Coquitlam, British Columbia
Pfizer Investigational Site
Corunna, Ontario
Pfizer Investigational Site
Cowansville, Quebec
Pfizer Investigational Site
Drummondville, Quebec
Pfizer Investigational Site
Edmonton, Alberta
Pfizer Investigational Site
Fort Erie, Ontario
Pfizer Investigational Site
Granby, Quebec
Pfizer Investigational Site
Halifax, Nova Scotia
Pfizer Investigational Site
Hamilton, Ontario
Pfizer Investigational Site
Langley, British Columbia
Pfizer Investigational Site
London, Ontario
Pfizer Investigational Site
Markham, Ontario
Pfizer Investigational Site
Mississauga, Ontario
Pfizer Investigational Site
Moncton, New Brunswick
Pfizer Investigational Site
Montague, Prince Edward Island
Pfizer Investigational Site
Montreal, Quebec
Pfizer Investigational Site
Mount Pearl
Pfizer Investigational Site
Newmarket, Ontario
Pfizer Investigational Site
Niagara Falls, Ontario
Pfizer Investigational Site
North Vancouver, British Columbia
Pfizer Investigational Site
Penticton, British Columbia
Pfizer Investigational Site
Québec, Quebec
Pfizer Investigational Site
Regina, Saskatchewan
Pfizer Investigational Site
Sainte-Julie, Quebec
Pfizer Investigational Site
Sherbrooke, Quebec
Pfizer Investigational Site
St. John's, Newfoundland and Labrador
Pfizer Investigational Site
Truro, Nova Scotia
Pfizer Investigational Site
Winnipeg, Manitoba
Pfizer Investigational Site
Woodstock, Ontario
About this study
Official title: A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.
To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.
Secondary outcomes (1)
To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Study completionOct 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants
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
- NCT00174395
- Sponsor's protocol ID
- A1601107
- Status last verified
- Jan 2021
- First submitted
- 9 Sep 2005
- Last updated
- 27 Jan 2021
- Results posted
- 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 Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.
- ClinicalTrials.gov ID
- NCT00174395
- Acronym / sponsor ID
- A1601107
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Sep 2005 (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 evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of migraine with or without aura according to the recent IHS criteria.
- Migraine headaches must have been present for more than one year.
- History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.
Key exclusion criteria (3 listed)
- Subjects with current or past history of coronary artery disease.
- Pregnant or breastfeeding women.
- Subjects who have chronic daily headaches.
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 |
|---|---|---|
| eletriptan | Drug | – |
Primary outcome
To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.
1 secondary outcome
To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence
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.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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
33 sites in 1 country: 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 33 sites in Canada.
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 33 sites in Canada. 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?
To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.. 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.