Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210483
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-09-13
Brief Title:
A Study of 3 Dosage Strengths of Almotriptan Malate AXERT in the Treatment of Acute Migraine in Adolescents
Sponsor:
Janssen-Ortho LLC
Organization:
Janssen-Ortho LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study of Oral Almotriptan Malate AXERT 625 mg 125 mg and 25 mg in the Acute Treatment of Migraine in Adolescents
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 in treating acute migraine headaches in adolescents Amotriptan malate AXERT is approved for use in the treatment of acute migraine headache with or without aura in adults In this study adolescents will be given a single dose of study medication to treat one migraine headache
Detailed Description:
Amotriptan malate AXERT is approved for use in the treatment of acute migraine headache with or without aura in adults Other studies have shown that almotriptan is effective and well tolerated in adults Migraines in teenagersadolescents are very similar to migraines in adults except that the duration is usually less in adolescents they last 1 to 24 hours in adolescents This study will evaluate the usefulness of almotriptan malate AXERT in treating acute migraine headaches in adolescents This is a randomized double-blind parallel-group and placebo-controlled study During a 30-day run-in period patients will treat their migraines as they normally would During this time the frequency and severity of headaches will be recorded At the second visit patients will be randomized like with the toss of a coin to a treatment group to receive one oral dose of almotriptan malate AXERT 625 125 or 25 milligrams or placebo Approximately the same number of patients will be assigned to each of the four treatment groups Patients will take this one-time dose when the next migraine of at least moderate severity occurs Patients will record assessments in a diary for up to 24 hours after the study drug is given to help determine the drugs effect on headache pain intensity Patients will return for a third visit within 2 to 14 days from taking the study medication A physical examination electrocardiogram a painless test of the heart and laboratory tests will be performed at the first and third visits The objective of this study is to determine the effectiveness and tolerability of 3 dosage strengths of almotriptan malate AXERT in adolescents with migraine headaches
Almotriptan oral tablets 625 125 or 25 milligrams or placebo
Almotriptan oral tablets 625 125 or 25 milligrams or placebo
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