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NCT Number: NCT01286207

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 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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)

Other names: MK-0462, Maxalt

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)

Other names: MK-0462, Maxalt

Standard care

Drug

Active standard care

Primary outcomes

  1. 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

    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. Number of Participants With Serious Clinical Adverse Experiences

    Time frame: Up to 12 months

    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.

  3. Number of Participants With Drug-related Clinical Adverse Experiences

    Time frame: Up to 12 months

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.

  4. Number of Participants Who Discontinued Due to Clinical Adverse Experiences

    Time frame: Up to 12 months

  5. Number of Participants With Drug-related Lab Adverse Experiences

    Time frame: Up to 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
1997
Study completion
1997
First posted
Jan 31, 2011
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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