A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine

Organon and Co0 sites933 target enrollmentAugust 1995

ConditionsMigraine Headache

Interventionsrizatriptan benzoate (MK0462)

Drugsrizatriptan benzoate (MK0462)Comparator: sumatriptan Comparator: Placebo

Overview

Phase: Phase 3
Intervention: rizatriptan benzoate (MK0462)
Conditions: Migraine Headache
Sponsor: Organon and Co
Enrollment: 933
Primary Endpoint: Pain Relief at 2 Hours After Treatment
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.

Registry

clinicaltrials.gov

Start Date

August 1995

End Date

September 1996

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Participant was Pregnant or a nursing mother
•Participant had a history or current evidence of drug or alcohol abuse
•Participant had a history or clinical evidence of cardiovascular disease
•Participant had a clinically significant Electrocardiography (ECG) abnormality
•Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
•Participant had received treatment with an investigational device or compound within 30 days of the study
•Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
•Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
•Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium

Arms & Interventions

1

Rizatriptan

Intervention: rizatriptan benzoate (MK0462)

Outcomes

Primary Outcomes

Pain Relief at 2 Hours After Treatment

Time Frame: 2 hours after treatment

Participants 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

Time to Relief Within 2 Hours After Treatment

Time Frame: within 2 hours after treatment

Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).

Secondary Outcomes

Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])(24 hours)
Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities(2 hours after treatment)
Pain Free at 2 Hours After Treatment(2 hours after treatment)
Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment(2 hours after treatment)
Participants Who Used Escape Medication 2 Hours After the Treatment Dose(2 hours after treatment)