MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Drug: rizatriptan benzoate (MK0462); Drug: Comparator: sumatriptan; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 933
• Phase: Phase 3

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3; Placebo	Drug: Comparator: Placebo; Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
Experimental: 1; Rizatriptan	Drug: rizatriptan benzoate (MK0462); single dose 5 mg rizatriptan p.o.; Other Names: MK0462
Experimental: 2; Sumatriptan	Drug: Comparator: sumatriptan; single dose 50 mg sumatriptan p.o.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief at 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	2 hours after treatment
Time to Relief 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).	within 2 hours after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Free at 2 Hours After Treatment	Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).	2 hours after treatment
Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities	Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).	2 hours after treatment
Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment	Participants who recorded the presence or absence of the 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	Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.	2 hours after treatment
Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])	Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence	24 hours

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.
• Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x.
• Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x.

Study record dates

Study Major Dates

• Study Start: August 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 11, 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: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; 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: 0462-029; 2009_593