A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

Organon and Co0 sites108 target enrollmentMarch 24, 2009

ConditionsMigraine

Interventionsrizatriptan benzoate

Overview

Phase: Phase 3
Intervention: rizatriptan benzoate
Conditions: Migraine
Sponsor: Organon and Co
Enrollment: 108
Primary Endpoint: Pain Relief (PR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

Registry

clinicaltrials.gov

Start Date

March 24, 2009

End Date

October 22, 2009

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
•Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
•Patient can distinguish between migraine and other types of headache
•Patient agrees to remain abstinent or use effective birth control during the study

Exclusion Criteria

•Patient is pregnant or breast-feeding
•Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
•Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
•Patient was \> 50 years old at age of migraine onset
•Patient has history of heart disease
•Patient has uncontrolled hypertension
•Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
•Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
•Patient is taking more than one other migraine prophylactic medication
•Patient has repeatedly failed to respond to or tolerate rizatriptan

Arms & Interventions

A

Treatment Sequence A: rizatriptan, rizatriptan, placebo

Intervention: rizatriptan benzoate

B

Sequence B: rizatriptan, placebo, rizatriptan

Intervention: rizatriptan benzoate

C

Sequence C: placebo, rizatriptan, rizatriptan

Intervention: rizatriptan benzoate

Outcomes

Primary Outcomes

Pain Relief (PR)

Time Frame: 2 hours post dose

Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.