A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

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

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

Study Overview

• Status: Completed
• Conditions: Acute Migraine
• Intervention / Treatment: Drug: rizatriptan; Drug: Comparator: Placebo; Drug: Comparator: Sumatriptan

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
• Patient has uncontrolled hypertension
• Patient has a history of neoplastic disease
• Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
• Patient has a history of drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence A; Rizatriptan - Rizatriptan - Placebo	Drug: rizatriptan; Single dose of 10 mg orally disintegrating tablet at onset of migraine attack; Drug: Comparator: Placebo; Placebo to Rizatriptan
Experimental: Treatment Sequence B; Rizatriptan - Placebo - Rizatriptan	Drug: rizatriptan; Single dose of 10 mg orally disintegrating tablet at onset of migraine attack; Drug: Comparator: Placebo; Placebo to Rizatriptan
Experimental: Treatment Sequence C; Placebo - Rizatriptan - Rizatriptan	Drug: rizatriptan; Single dose of 10 mg orally disintegrating tablet at onset of migraine attack; Drug: Comparator: Placebo; Placebo to Rizatriptan
Other: Baseline Phase; Sumatriptan	Drug: Comparator: Sumatriptan; single dose of generic sumatriptan 100 mg at onset of migraine attack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief (PR)	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.	2 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Freedom (PF)	Headache pain severity, relative to the administration of study medication, 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 freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.	2 hours post dose

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Seeburger JL, Taylor FR, Friedman D, Newman L, Ge Y, Zhang Y, Hustad CM, Lasorda J, Fan X, Hewitt D, Ho T, Connor KM. Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia. 2011 May;31(7):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2009
• Primary Completion (Actual): January 12, 2010
• Study Completion (Actual): January 12, 2010

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 6, 2009
• First Posted (Estimate): May 7, 2009

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Treatment of acute migraine with or without aura in adults
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Rizatriptan; Sumatriptan
• Other Study ID Numbers: 0462-087; 2009_587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php