Clinical trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Name

0462-081

Description

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

Trial arms

Trial start

2007-10-03

Estimated PCD

2008-04-08

Trial end

2008-04-08

Status

Completed

Phase

Early phase I

Treatment

Comparator: rizatriptan benzoate

Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack

Arms:

Other names:

MK0462

Comparator: Placebo

Matching placebo; one dose, treatment of a single migraine attack

Arms:

Size

207

Primary endpoint

Number of Participants Who Are Pain Free at 2 Hours Post-Dose

2 hours post-dose

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 207, 'type': 'ACTUAL'}}

Updated at

2024-04-22

1 organization

2 products

1 indication

Organization

Product

Indication

Product