Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212823
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Brief Title:
The Effectiveness of Almotriptan Malate AXERT 125 Milligrams When Taken at the Onset of Migraine Pain
Sponsor:
Ortho-McNeil Neurologics Inc
Organization:
Ortho-McNeil Neurologics Inc
Study Overview
Official Title:
AXERT 125mg Time vs Intensity Migraine Study AIMS An Open-label Multicenter Trial to Evaluate the Efficacy of Almotriptan Malate AXERT 125 Milligram Intervention at Onset of Migraine Pain
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 125 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 125 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 125 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 125 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 125 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
AXERT 125 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None