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

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286207
• Other study ID #: 0462 Pooled 022/025/029
• Status: Completed
• Phase: Phase 3
• Start date: March 1995
• Est. completion date: May 1997

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1959
• Est. completion date: May 1997
• Est. primary completion date: May 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• 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 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
Active standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of Participants Who Discontinued Due to Clinical Adverse Experiences		Up to 12 months
Primary	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