Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

Phase 3

Completed

Brief Summary: A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Patient was pregnant or a nursing mother
Patient had abused drugs or alcohol within 12 months prior to entering the study
Patient had a history of cardiovascular disease
Patient had clinically significant Electrocardiography (ECG) abnormality
Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
Patient received treatment with an investigational device or compound within 30 days of the study start
Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
Patient had hypersensitivity to sumatriptan
Patient had participated in any previous study involving rizatriptan

Arm && Interventions

Group	Intervention	Description
2	rizatriptan benzoate	rizatriptan 10 mg
1	rizatriptan benzoate	rizatriptan 5 mg

Primary Outcome Measures

Name	Time	Method
Time to Relief Within 2 Hours After Dose	within 2 hours after dose	Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Pain Relief at 2 Hours After Dose	2 hours after dose	Patients 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

Secondary Outcome Measures

Name	Time	Method
Pain Free at 2 Hours After Dose	2 hours after dose	Patients pain free (defined as a reduction of headache severity to grade 0 \[no pain\]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Functional Status at 2 Hours After Dose	2 hours after dose	Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).
Nausea at 2 Hours After Dose	2 hours after dose	Patients who recorded the presence or absence of nausea 2 hours after dose