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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01286207
First received: January 27, 2011
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
Drug: Rizatriptan 5 mg
Drug: Rizatriptan 10 mg
Drug: Standard Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Number of Participants With Drug-related Lab Adverse Experiences [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 1959
Study Start Date: March 1995
Study Completion Date: May 1997
Primary Completion Date: May 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
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)
Other Name: MK-0462, Maxalt
Experimental: 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)
Drug: 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)
Other Name: MK-0462, Maxalt
Active Comparator: Standard Care
Standard care at onset of migraine attack
Drug: Standard Care
Active standard care

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
  • History of migraine headache
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01286207     History of Changes
Other Study ID Numbers: 0462 Pooled 022/025/029
Study First Received: January 27, 2011
Results First Received: May 20, 2011
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Migraine headache

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Rizatriptan
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on October 23, 2014