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

Organon

Status and phase: Completed; Phase 3

Conditions: Migraine Headache

Treatments: Drug: rizatriptan benzoate (MK0462); Drug: Comparator: sumatriptan; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00897104

0462-029

2009_593

Details and patient eligibility

About

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.

Enrollment: 933 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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933 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Rizatriptan

Treatment:

Drug: rizatriptan benzoate (MK0462)

2

Experimental group

Description:

Sumatriptan

Treatment:

Drug: Comparator: sumatriptan

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo