Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

February 1, 2022 updated by: Organon and Co

A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine

A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1268

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

16 years to 63 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 Electrocardiography (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 hypersensitivity to sumatriptan
  • Patient had participated in any previous study involving 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
Placebo Comparator: 4
placebo
Drug: Comparator: Placebo
placebo to rizatriptan
Experimental: 1
rizatriptan 5 mg
Drug: rizatriptan benzoate
single dose administration of 5mg rizatriptan (by Mouth) p.o.
Other Names:
  • MK0462
  • rizatriptan
Drug: rizatriptan benzoate
single dose administration of 10 mg rizatriptan p.o.
Other Names:
  • MK0462
  • rizatriptan
Experimental: 2
rizatriptan 10 mg
Drug: rizatriptan benzoate
single dose administration of 5mg rizatriptan (by Mouth) p.o.
Other Names:
  • MK0462
  • rizatriptan
Drug: rizatriptan benzoate
single dose administration of 10 mg rizatriptan p.o.
Other Names:
  • MK0462
  • rizatriptan
Active Comparator: 3
sumatriptan 100 mg
Drug: Comparator: sumatriptan
single dose administration of sumatriptan 100 p.o.
Other Names:
  • sumatriptan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief at 2 Hours After Dose
Time Frame: 2 hours after dose
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
2 hours after dose
Time to Relief Within 2 Hours After Dose
Time Frame: within 2 hours after dose
Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
within 2 hours after dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Free at 2 Hours After Dose
Time Frame: 2 hours after dose
Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
2 hours after dose
Functional Status at 2 Hours After Dose
Time Frame: 2 hours after dose
Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).
2 hours after dose
Nausea at 2 Hours After Dose
Time Frame: 2 hours after dose
Patients who recorded the presence or absence of nausea 2 hours after dose
2 hours after dose

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

September 1, 1995

Primary Completion (Actual)

May 1, 1996

Study Completion (Actual)

September 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

  • 0462-030
  • 2009_591

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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