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

NCT01286207 | Completed Phase 3 Results

• 1 other identifier: 0462 Pooled 022/025/029
• Study Type: interventional
• Target: 1,959
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders

Keywords

Migraine headache

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Rizatriptan 5 mg

EXPERIMENTAL

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

Rizatriptan 10 mg

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

Standard care at onset of migraine attack

Drug: Standard Care

Interventions

Rizatriptan 5 mg DRUG

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)

Also known as: MK-0462, Maxalt

Rizatriptan 5 mg

Rizatriptan 10 mg DRUG

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)

Also known as: MK-0462, Maxalt

Rizatriptan 10 mg

Standard Care DRUG

Active standard care

Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan; Standard of Care

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: March 1, 1995
• Primary Completion: May 1, 1997
• Study Completion: May 1, 1997
• Last Updated: February 3, 2022
• Results First Posted: June 10, 2011

Record last verified: 2022-02