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