A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

Organon and Co0 sites109 target enrollmentJune 10, 2009

ConditionsAcute Migraine

Interventionsrizatriptan

Overview

Phase: Phase 3
Intervention: rizatriptan
Conditions: Acute Migraine
Sponsor: Organon and Co
Enrollment: 109
Primary Endpoint: Pain Relief (PR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

Registry

clinicaltrials.gov

Start Date

June 10, 2009

End Date

January 12, 2010

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 1 year or more with 2-8 moderate or severe migraine attacks per month
•Patient generally does not respond to treatment with sumatriptan
•Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
•Patient is able to complete paper diary

Exclusion Criteria

•Patient is pregnant or breast feeding or excepts to become pregnant during the study
•Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
•Patient has basilar or hemiplegic migraines
•Patient is unable to distinguish between migraine attacks from other types of headaches
•Patient has more than 15 headache-days per month
•Patient was greater than 50 years old at age of migraine onset
•Patient has failed to respond to 3 or more triptans
•Patient has a repeated history of failing to respond to or tolerate rizatriptan
•Patient uses opioids as primary migraine therapy
•Patient uses daily opioids

Arms & Interventions

Treatment Sequence A

Rizatriptan - Rizatriptan - Placebo

Intervention: rizatriptan

Treatment Sequence B

Rizatriptan - Placebo - Rizatriptan

Intervention: rizatriptan

Treatment Sequence C

Placebo - Rizatriptan - Rizatriptan

Intervention: rizatriptan

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.