Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 207
• 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:

• Greater than one year history of migraine
• Attacks typically mild when they begin and progress to moderate or severe
• Experience 1-4 migraine attacks per month

Exclusion Criteria:

• More than 15 headache days per month
• Heart disease
• Uncontrolled high blood pressure

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Active Drug	Drug: Comparator: rizatriptan benzoate; Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack; Other Names: MK0462
Placebo Comparator: 2; Matching Pbo Comparator	Drug: Comparator: Placebo; Matching placebo; one dose, treatment of a single migraine attack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Are Pain Free at 2 Hours Post-Dose	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.	2 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 24-Hour Sustained Pain Freedom	24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.	24 hours post-dose
Number of Participants With no Rescue Use up to 24 Hours Post-Dose	Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.	24 hours post-dose
Number of Participants With Absence of Photophobia at 2 Hours Post-dose	Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.	2 hours post-dose
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose	Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.	2 hours post-dose
Number of Participants With Absence of Nausea at 2 Hours Post-dose	Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.	2 hours post-dose
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose	Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.	2 hours post-dose

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2007
• Primary Completion (Actual): April 8, 2008
• Study Completion (Actual): April 8, 2008

Study Registration Dates

• First Submitted: August 13, 2007
• First Submitted That Met QC Criteria: August 13, 2007
• First Posted (Estimate): August 15, 2007

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

• 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 Receptor Agonists; Rizatriptan
• Other Study ID Numbers: 0462-081; 2007_547

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