NCT00397254

Two Rizatriptan Prescribing Portions for Treatment of Migraine

An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Clinvest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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, and/or 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	rizatriptan	10mg ODT 27 tablets
DRUG	rizatriptan	10mg ODT 9 tablets

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-11-09
• Last updated: 2010-06-08
• Results posted: 2009-09-22

Locations

10 sites across 1 country: United States