NCT00897104CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 933
- Primary Endpoint
- Pain Relief at 2 Hours After Treatment
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Rizatriptan
Intervention: rizatriptan benzoate (MK0462) (Drug)
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)
Investigators
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