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

Study Overview
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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.

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

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Rizatriptan 5 mg
* Drug: Rizatriptan 10 mg
* Drug: Standard Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rizatriptan 5 mg<br>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) | Drug: Rizatriptan 5 mg<br>* 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)<br>* Other names: MK-0462, Maxalt;|
| Experimental: Rizatriptan 10 mg<br>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) | Drug: Rizatriptan 10 mg<br>* 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)<br>* Other names: MK-0462, Maxalt;|
| Active Comparator: Standard Care<br>Standard care at onset of migraine attack | Drug: Standard Care<br>* Active standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patient's Headaches With Pain Relief at 2 Hours After the 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. | 2 hours after initial dose of test drug | 
| Number of Participants With Serious Clinical Adverse Experiences | 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. | Up to 12 months | 
| Number of Participants With Drug-related Clinical Adverse Experiences | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs. | Up to 12 months | 
| Number of Participants Who Discontinued Due to Clinical Adverse Experiences |  | Up to 12 months | 
| Number of Participants With Drug-related Lab Adverse Experiences | 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. | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine headache