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

Phase 3

Completed

Conditions: Migraine Headache

Interventions: Drug: rizatriptan benzoate (MK0462)

Registration Number: NCT00897104

Lead Sponsor: Organon and Co

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 933

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	rizatriptan benzoate (MK0462)	Rizatriptan

Primary Outcome Measures

Name	Time	Method
Pain Relief at 2 Hours After Treatment	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	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 Outcome Measures

Name	Time	Method
Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])	24 hours	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
Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities	2 hours after treatment	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).
Pain Free at 2 Hours After Treatment	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).
Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment	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.
Participants Who Used Escape Medication 2 Hours After the Treatment Dose	2 hours after treatment	Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.