Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397254
Status:
COMPLETED
Last Update Posted:
2010-06-08
First Post:
2006-11-07
Brief Title:
Two Rizatriptan Prescribing Portions for Treatment of Migraine
Sponsor:
Clinvest
Organization:
Clinvest
Study Overview
Official Title:
An Observer-Blind Randomized Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine
Status:
COMPLETED
Status Verified Date:
2009-09
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 primary objective of this study is to evaluate a clinical limit CL of rizatriptan 9 rizatriptan 10mg Orally Disintegrating Tablet ODT per month versus vs a formulary limit FL of rizatriptan 27 rizatriptan 10mg ODT per month as measured by the number of days of migraine per month
Detailed Description:
A common clinical perception exists that less effective treatment of attacks increases the burden of disease across attacks in the form of increased attack frequency severity duration andor treatability If this perception is true more effective treatment decreases the burden of disease across attacks There are multiple barriers to effective treatment The triptan class of migraine medications is frequently dispensed in the context of health benefit plan formulary limitations Because of limited supply medications must be used very cautiously Patients may hoard medication in reaction to fear of running out Overly cautious use and hoarding may lead to greater disease burden
The purpose of this study is to compare the effect of two allocations of rizatriptan - a more limited allocation Formulary Limit vs a less limited allocation Clinical Limit on disease burden
The purpose of this study is to compare the effect of two allocations of rizatriptan - a more limited allocation Formulary Limit vs a less limited allocation Clinical Limit on disease burden
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