Migraine Disorders Clinical Trial
Official title:
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
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. |
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