Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)

Organon

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders

Treatments: Drug: Rizatriptan 5 mg; Drug: Rizatriptan 10 mg; Drug: Standard Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01286207

0462 Pooled 022/025/029

Details and patient eligibility

About

This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.

Enrollment: 1,959 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
• History of migraine headache

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,959 participants in 3 patient groups

Rizatriptan 5 mg

Experimental group

Description:

Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)

Treatment:

Drug: Rizatriptan 5 mg

Rizatriptan 10 mg

Experimental group

Description:

Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)

Treatment:

Drug: Rizatriptan 10 mg

Standard Care

Active Comparator group

Description:

Standard care at onset of migraine attack

Treatment:

Drug: Standard Care