Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

Organon

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Comparator: Placebo; Drug: Comparator: rizatriptan benzoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516737

0462-081

2007_547

Details and patient eligibility

About

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than one year history of migraine
• Attacks typically mild when they begin and progress to moderate or severe
• Experience 1-4 migraine attacks per month

Exclusion criteria

• More than 15 headache days per month
• Heart disease
• Uncontrolled high blood pressure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Active Drug

Treatment:

Drug: Comparator: rizatriptan benzoate

2

Placebo Comparator group

Description:

Matching Pbo Comparator

Treatment:

Drug: Comparator: Placebo