Treatment of Multiple Attacks of Acute Migraine (0462-025)

February 1, 2022 updated by: Organon and Co

A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache

A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

473

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient had at least a 6-month history of migraine, with or without aura
  • Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
  • Patient was judged to be in good health, apart from migraine

Exclusion Criteria:

  • Patient was pregnant or a nursing mother.
  • Patient had abused drugs or alcohol within 12 months prior to entering the study
  • Patient had a history of cardiovascular disease
  • Patient had clinically significant ECG abnormality
  • Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
  • Patient received treatment with an investigational device or compound within 30 days of the study start
  • Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
  • Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
  • Patient had prior exposure to rizatriptan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Sequence 1
Placebo-Rizatriptan-Rizatriptan-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Names:
  • MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 2
Rizatriptan-Placebo-Rizatriptan-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Names:
  • MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 3
Rizatriptan-Rizatriptan-Placebo-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Names:
  • MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 4
Rizatriptan-Rizatriptan-Rizatriptan-Placebo
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Names:
  • MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 5
Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Names:
  • MK0462

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief at 2 Hours During the First Migraine Attack Period
Time Frame: 2 hours
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief at 2 Hours During the Second Migraine Attack Period
Time Frame: 2 hours
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack
2 hours
Pain Relief at 2 Hours During the Third Migraine Attack Period
Time Frame: 2 hours
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack
2 hours
Pain Relief at 2 Hours During the Fourth Migraine Attack Period
Time Frame: 2 hours
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1995

Primary Completion (Actual)

January 1, 1996

Study Completion (Actual)

April 1, 1996

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 8, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

February 3, 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

Other Study ID Numbers

  • 0462-025
  • MK0462-025
  • 2009_590

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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