Back to resultsLong-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rizatriptan 5 mg
Rizatriptan 10 mg
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine headache
Eligibility Criteria
Inclusion Criteria:
- Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
- History of migraine headache
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Rizatriptan 5 mg
Rizatriptan 10 mg
Standard Care
Arm 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)
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 at onset of migraine attack
Outcomes
Primary Outcome Measures
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.
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.
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.
Number of Participants Who Discontinued Due to Clinical Adverse Experiences
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01286207
Brief Title
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
Official Title
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
May 1997 (Actual)
Study Completion Date
May 1997 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Migraine headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1959 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rizatriptan 5 mg
Arm Type
Experimental
Arm 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)
Arm Title
Rizatriptan 10 mg
Arm Type
Experimental
Arm 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)
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard care at onset of migraine attack
Intervention Type
Drug
Intervention Name(s)
Rizatriptan 5 mg
Other Intervention Name(s)
MK-0462, Maxalt
Intervention 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)
Intervention Type
Drug
Intervention Name(s)
Rizatriptan 10 mg
Other Intervention Name(s)
MK-0462, Maxalt
Intervention 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)
Intervention Type
Drug
Intervention Name(s)
Standard Care
Intervention Description
Active standard care
Primary Outcome Measure Information:
Title
Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug
Description
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.
Time Frame
2 hours after initial dose of test drug
Title
Number of Participants With Serious Clinical Adverse Experiences
Description
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.
Time Frame
Up to 12 months
Title
Number of Participants With Drug-related Clinical Adverse Experiences
Description
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Time Frame
Up to 12 months
Title
Number of Participants Who Discontinued Due to Clinical Adverse Experiences
Time Frame
Up to 12 months
Title
Number of Participants With Drug-related Lab Adverse Experiences
Description
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.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
History of migraine headache
12. IPD Sharing Statement
Learn more about this trial
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
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