MigrainePhase 4NCT00632385
Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
A Phase 4 study testing Eletriptan in people with Migraine, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 16 sites in United States.
Trial summary
To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 16 sitesUnited States
- Study dates
- Jan 2003to Aug 2003
- 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 headache according to International Headache Society criteria and migraine headaches for at least 1 year
- Eletriptan naive
- Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months
Who cannot join
- Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
- Migraine attacks that are atypical or chronic daily headaches
- A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Pfizer Investigational Site
Alexandria, Virginia, 22304
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Greensboro, North Carolina, 27403
Pfizer Investigational Site
Irvine, California, 92618
Pfizer Investigational Site
Marietta, Georgia, 30067
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Newport Beach, California, 92660-2452
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Francisco, California, 94109
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
Springfield, Missouri, 65804
Pfizer Investigational Site
St. Petersburg, Florida, 33710
Pfizer Investigational Site
Tampa, Florida, 33609
About this study
Official title: An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy
To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy
- 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
40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Eletriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in headache pain severity
Measured: 1, 2, 4, and 24 hours
Secondary outcomes (11)
Functional impairment
Measured: 1, 2, 4, and 24 hours
Work Productivity Questionnaire
Measured: Week 10
Time Loss
Measured: Week 10
Subject Preference Questionnaire
Measured: Week 10
Global Evaluation
Measured: Week 10
Subject Satisfaction Scale
Measured: Week 10
Associated Symptoms
Measured: 1, 2, 4, and 24 hours
Use of Rescue Medication
Measured: Week 10
Adverse events
Measured: Week 10
Vital signs
Measured: Week 10
Physical examination
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startJan 2003
- Study completionAug 2003
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
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
- NCT00632385
- Sponsor's protocol ID
- A1601092
- Status last verified
- Jan 2021
- First submitted
- 3 Mar 2008
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- 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
- An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy
- ClinicalTrials.gov ID
- NCT00632385
- Acronym / sponsor ID
- A1601092
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Aug 2003 (actual)
- First posted
- 10 Mar 2008 (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 assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Eletriptan |
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 headache according to International Headache Society criteria and migraine headaches for at least 1 year
- Eletriptan naive
- Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months
Key exclusion criteria (3 listed)
- Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
- Migraine attacks that are atypical or chronic daily headaches
- A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura
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 |
|---|---|---|
| Eletriptan40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose | Drug | A |
Primary outcome
Change from baseline in headache pain severity
Time frame: 1, 2, 4, and 24 hours
11 secondary outcomes
Functional impairment
Time frame: 1, 2, 4, and 24 hours
Work Productivity Questionnaire
Time frame: Week 10
Time Loss
Time frame: Week 10
Subject Preference Questionnaire
Time frame: Week 10
Global Evaluation
Time frame: Week 10
Subject Satisfaction Scale
Time frame: Week 10
Associated Symptoms
Time frame: 1, 2, 4, and 24 hours
Use of Rescue Medication
Time frame: Week 10
Adverse events
Time frame: Week 10
Vital signs
Time frame: Week 10
Physical examination
Time frame: Week 10
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
16 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 16 sites in United States.
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 16 sites in United States. 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?
Change from baseline in headache pain severity (time frame: 1, 2, 4, and 24 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 27 Jan 2021.