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

NCT ID: NCT01286207

Last Updated: 2022-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1959 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-03-31

Study Completion Date

1997-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Rizatriptan 5 mg

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)

Group Type EXPERIMENTAL

Rizatriptan 5 mg

Intervention Type DRUG

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)

Rizatriptan 10 mg

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)

Group Type EXPERIMENTAL

Rizatriptan 10 mg

Intervention Type DRUG

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)

Standard Care

Standard care at onset of migraine attack

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type DRUG

Active standard care

Interventions

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Rizatriptan 5 mg

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)

Intervention Type DRUG

Rizatriptan 10 mg

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)

Intervention Type DRUG

Standard Care

Active standard care

Intervention Type DRUG

Other Intervention Names

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MK-0462, Maxalt MK-0462, Maxalt

Eligibility Criteria

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Inclusion Criteria

* Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
* History of migraine headache
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0462 Pooled 022/025/029

Identifier Type: -

Identifier Source: org_study_id

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