Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210496
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-09-13
Brief Title:
Potential Impact Benefit of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine
Sponsor:
Janssen-Ortho LLC
Organization:
Janssen-Ortho LLC
Study Overview
Official Title:
Efficacy of AXERT Almotriptan Malate in the Acute Treatment of Migraine A Pilot Study of the Potential Impact of Preventive Therapy With TOPAMAX Topiramate
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 impact of topiramate migraine prevention medicine on the effectiveness of almotriptan malate acute migraine medicine when treating acute migraine headaches
Detailed Description:
Migraine afflicts greater than 28 million adults in the United States Acute treatments such as almotriptan malate target the symptoms of a migraine attack Preventive treatments such as topiramate primarily target the generation of attacks and may decrease use of acute treatments Preventive treatments by a process of neurostabilization may result in an additive effect on almotriptan malate to improve acute treatment intervention response during a migraine attack This is a randomized double blind parallel group multicenter study that will enroll patients 18-65 years old with a history of 3-12 migraine headaches each month for the past 3 months The total study duration will be approximately 32 weeks The study is divided into 4 phases as follows A Screening Phase that lasts one month An Open Label Phase where all patients will be treated with topiramate gradually dosed to 100mg a day lasting 6 weeks A Double Blind Phase lasting 19 weeks at which time patients will be randomized to stay on topiramate 100mg per day or switch to placebo topiramate 5050 chance and a TaperExit Phase lasting 2 weeks Almotriptan malate will be used for all migraine headaches during the study as needed The study hypothesis is that the combination of almotriptan malate and topiramate will have a better clinical response than the combination of almotriptan malate and placebo topiramate Migraine pain information will be collected from each patient with the use of a Personal Digital Assistant PDA or Palm Pilot throughout the study for each migraine attack Commercial Topiramate will be gradually increased to 100mgday in approximately 4-6 weeks You will then be randomized to either Topiramate or Placebo dosed at 100mg a day for the remainder of the study 18 weeks AXERT 125mg may be taken to treat migraine headaches during the study
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