Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210509
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-09-13
Brief Title:
A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache
Sponsor:
Janssen-Ortho LLC
Organization:
Janssen-Ortho LLC
Study Overview
Official Title:
AXERT Early miGraine Intervention Study AEGIS Efficacy and Safety of Almotriptan Malate AXERT Versus Placebo for the Acute Treatment of Migraine Headache
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 almotriptan malate AXERT 125 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain Almotriptan malate AXERT is approved for the treatment of migraine headache with or without aura in adults Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches
Detailed Description:
Almotriptan malate AXERT is approved for the treatment of migraine headache with or without aura in adults This is a multicenter randomized double-blind placebo-controlled parallel group study of adult patients with a diagnosis of migraine headache with or without aura Patients will be randomized like with the toss of a coin to receive almotriptan malate AXERT or placebo for the treatment of 3 consecutive qualifying migraine headaches After screening patients will leave the study center with blinded study medication and an electronic subject diary Personal Digital Assistant PDA Patients will self-dose with study medication as soon as headache pain of any intensity begins that resembles their usual migraine but no later than 1 hour after headache pain begins Patients will use their PDAs to record assessments such as pain intensity symptom severity and ability to function as related to the headaches The primary hypothesis of this study is that the percentage of patients who are pain free two hours after taking study drug at the earliest onset of headache pain is greater in the almotriptan malate AXERT 125mg group than in the placebo group and almotriptan malate AXERT is generally well-tolerated
Almotriptan malate AXERT 125 milligrams or placebo tablets one by mouth at the beginning of migraine pain within 1 hour for 3 consecutive migraine headaches
Almotriptan malate AXERT 125 milligrams or placebo tablets one by mouth at the beginning of migraine pain within 1 hour for 3 consecutive migraine headaches
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