MigrainePhase 4NCT00212823
The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain
A Phase 4 study testing almotriptan malate in people with Migraine, run by Ortho-McNeil Neurologics, Inc..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating a migraine at the onset of headache pain, as compared to treating a migraine only after the headache pain has reached at least moderate intensity.. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- almotriptan malate
- How many people
- 1,450 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Feb 2005
- 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
- History of a confirmed diagnosis of migraine headache with or without aura that meets the International Headache Society (IHS) criteria of migraine headache for at least 1 year
- Average frequency of 1 - 6 migraine headaches per month over the past 3 months
- History of migraine headaches of at least moderate pain intensity within the past year
- If taking a medication for migraine prophylaxis, taking a maintenance dose for at least 4 weeks prior to Visit 1, and remaining on a stable dose for the duration of the study
- In generally good health
- Capable of taking oral medication, perform study procedures and follow directions regarding collection of study information, e.g., subjects must be able and willing to read and comprehend written instructions, use a stopwatch, and comprehend and complete the telephone requirements, and must be willing to return to the office for a final study visit
- If female of childbearing potential, using birth control
Who cannot join
- Onset of migraine after age 50
- Chronic migraine or chronic tension-type headache defined by having 15 or more headache days per month in the previous 6 months
- Exclusively migraine aura without headache, or headaches that occur predominantly upon awakening in the morning
- Patients in whom triptans are contraindicated or who have previously discontinued AXERT therapy due to adverse events, history of substance abuse, or chronic alcohol abuse within the past 6 months
About this study
Official title: AXERT® 12.5mg Time vs Intensity Migraine Study (AIMS): An Open-label Multicenter Trial to Evaluate the Efficacy of Almotriptan Malate (AXERT®) 12.5 Milligram Intervention at Onset of Migraine Pain
The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating a migraine at the onset of headache pain, as compared to treating a migraine only after the headache pain has reached at least moderate intensity..
Read the detailed description
AXERT has been approved by the FDA for the treatment of migraine headache with or without aura in adults. Early treatment of a migraine headache, independent of headache pain intensity symptoms, may provide the optimal therapeutic response. This is a multi-center, open label study to test the efficacy (effectiveness) and tolerability of AXERT when treating a migraine at the onset of headache pain versus treating a migraine only after the headache pain has reached at least moderate intensity. Patients will self-administer 12.5 milligrams of AXERT for the treatment of 2 migraine headaches. Centers will be randomly assigned to 1 of 2 treatment interventions in which patients will sequentially treat both migraine headaches with 12.5 milligrams of AXERT using either the early treatment regimen (ET; ie, at the onset of pain) or conditional treatment regimen (CT; ie, after the headache has reached at least moderate intensity). Data will be collected regarding treatment response during and after each migraine headache. For each headache, patients will record study information and data during 3 telephone calls using Interactive Voice Response System (IVRS) technology. It is expected that patients who take 12.5 milligrams of AXERT at the first sign of pain of any intensity due to a migraine headache will experience an overall shorter duration of their migraine than patients who take AXERT 12.5 mg when their migraine pain has reached at least moderate pain intensity. In addition, it is expected that almotriptan malate (AXERT®) is generally well-tolerated.
AXERT 12.5 milligram tablet orally either at the onset of migraine pain (within 1 hour of the start of a migraine-ET regimen) or when migraine pain reaches at least moderate intensity (CT regimen).
- Conditions
- Migraine
- Being tested
- almotriptan malate
- Keywords
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
almotriptan malateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of migraine pain measured from onset of pain to no pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho McNeil Neurologics, Inc. Clinical Trial, Study director, Ortho-McNeil Neurologics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212823
- Sponsor's protocol ID
- CR004708
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Freitag FG, Finlayson G, Rapoport AM, Elkind AH, Diamond ML, Unger JR, Fisher AC, Armstrong RB, Hulihan JF, Greenberg SJ; AIMS Investigators. Effect of pain intensity and time to administration on responsiveness to almotriptan: results from AXERT 12.5 mg Time Versus Intensity Migraine Study (AIMS). Headache. 2007 Apr;47(4):519-30. doi: 10.1111/j.1526-4610.2007.00756.x.
PubMed 17445101
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXERT® 12.5mg Time vs Intensity Migraine Study (AIMS): An Open-label Multicenter Trial to Evaluate the Efficacy of Almotriptan Malate (AXERT®) 12.5 Milligram Intervention at Onset of Migraine Pain
- ClinicalTrials.gov ID
- NCT00212823
- Acronym / sponsor ID
- CR004708
- Conditions
- Migraine
- Keywords
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Feb 2005 (actual)
- First posted
- 21 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.
The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating a migraine at the onset of headache pain, as compared to treating a migraine only after the headache pain has reached at least moderate intensity..
Detailed description
AXERT has been approved by the FDA for the treatment of migraine headache with or without aura in adults. Early treatment of a migraine headache, independent of headache pain intensity symptoms, may provide the optimal therapeutic response. This is a multi-center, open label study to test the efficacy (effectiveness) and tolerability of AXERT when treating a migraine at the onset of headache pain versus treating a migraine only after the headache pain has reached at least moderate intensity. Patients will self-administer 12.5 milligrams of AXERT for the treatment of 2 migraine headaches. Centers will be randomly assigned to 1 of 2 treatment interventions in which patients will sequentially treat both migraine headaches with 12.5 milligrams of AXERT using either the early treatment regimen (ET; ie, at the onset of pain) or conditional treatment regimen (CT; ie, after the headache has reached at least moderate intensity). Data will be collected regarding treatment response during and after each migraine headache. For each headache, patients will record study information and data during 3 telephone calls using Interactive Voice Response System (IVRS) technology. It is expected that patients who take 12.5 milligrams of AXERT at the first sign of pain of any intensity due to a migraine headache will experience an overall shorter duration of their migraine than patients who take AXERT 12.5 mg when their migraine pain has reached at least moderate pain intensity. In addition, it is expected that almotriptan malate (AXERT®) is generally well-tolerated.
AXERT 12.5 milligram tablet orally either at the onset of migraine pain (within 1 hour of the start of a migraine-ET regimen) or when migraine pain reaches at least moderate intensity (CT regimen).
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 (7 listed)
- History of a confirmed diagnosis of migraine headache with or without aura that meets the International Headache Society (IHS) criteria of migraine headache for at least 1 year
- Average frequency of 1 - 6 migraine headaches per month over the past 3 months
- History of migraine headaches of at least moderate pain intensity within the past year
- If taking a medication for migraine prophylaxis, taking a maintenance dose for at least 4 weeks prior to Visit 1, and remaining on a stable dose for the duration of the study
- In generally good health
Key exclusion criteria (4 listed)
- Onset of migraine after age 50
- Chronic migraine or chronic tension-type headache defined by having 15 or more headache days per month in the previous 6 months
- Exclusively migraine aura without headache, or headaches that occur predominantly upon awakening in the morning
- Patients in whom triptans are contraindicated or who have previously discontinued AXERT therapy due to adverse events, history of substance abuse, or chronic alcohol abuse within the past 6 months
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 |
|---|---|---|
| almotriptan malate | Drug | – |
Primary outcome
Duration of migraine pain measured from onset of pain to no pain.
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 19 May 2011.
- Results publication: PubMed 17445101Freitag FG, Finlayson G, Rapoport AM, Elkind AH, Diamond ML, Unger JR, Fisher AC, Armstrong RB, Hulihan JF, Greenberg SJ; AIMS Investigators. Effect of pain intensity and time to administration on responsiveness to almotriptan: results from AXERT 12.5 mg Time Versus Intensity Migraine Study (AIMS). Headache. 2007 Apr;47(4):519-30. doi: 10.1111/j.1526-4610.2007.00756.x.
- AXERT 12.5mg Time vs Intensity - Migraine Study (AIMS)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.
Ortho McNeil Neurologics, Inc. Clinical Trial study director
Ortho-McNeil Neurologics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing almotriptan malate in people with Migraine, run by Ortho-McNeil Neurologics, 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 7 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 19 May 2011. 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. 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?
Duration of migraine pain measured from onset of pain to no pain.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212823, which also lists 1 linked publication.
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 19 May 2011.