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

Phase 3

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Standard Care; Drug: Rizatriptan 5 mg; Drug: Rizatriptan 10 mg

• Registration Number: NCT01286207
• Lead Sponsor: Organon and Co

Brief Summary

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

Not available

Study Timeline

• Study Start: 1995-03
• Primary Completion: 1997-05
• Study Completion: 1997-05
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Results First Submitted: 2011-05-20
• Results First Submitted QC: 2011-05-20
• Results First Posted: 2011-06-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1959

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Standard care at onset of migraine attack
Rizatriptan 5 mg	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)
Rizatriptan 10 mg	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)

Primary Outcome Measures

Name	Time	Method
Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug	2 hours after initial dose of test drug	Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.
Number of Participants With Serious Clinical Adverse Experiences	Up to 12 months	Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Number of Participants With Drug-related Clinical Adverse Experiences	Up to 12 months	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Number of Participants Who Discontinued Due to Clinical Adverse Experiences	Up to 12 months
Number of Participants With Drug-related Lab Adverse Experiences	Up to 12 weeks	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE).; A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.