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Completed

NCT Number: NCT00516737

Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

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Key information

Conditions

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

Age range

18 year and older

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

  • Greater than one year history of migraine
  • Attacks typically mild when they begin and progress to moderate or severe
  • Experience 1-4 migraine attacks per month

Exclusion criteria

  • More than 15 headache days per month
  • Heart disease
  • Uncontrolled high blood pressure

Treatment and study plan

Comparator: rizatriptan benzoate

Drug

Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack

Other names: MK0462

Comparator: placebo

Drug

Matching placebo; one dose, treatment of a single migraine attack

Primary outcomes

  1. Number of Participants Who Are Pain Free at 2 Hours Post-Dose

    Time frame: 2 hours post-dose

    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

Secondary outcomes

  1. Number of Participants With 24-Hour Sustained Pain Freedom

    Time frame: 24 hours post-dose

    24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.

  2. Number of Participants With no Rescue Use up to 24 Hours Post-Dose

    Time frame: 24 hours post-dose

    Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.

  3. Number of Participants With Absence of Photophobia at 2 Hours Post-dose

    Time frame: 2 hours post-dose

    Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.

  4. Number of Participants With Absence of Phonophobia at 2 Hours Post-dose

    Time frame: 2 hours post-dose

    Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.

  5. Number of Participants With Absence of Nausea at 2 Hours Post-dose

    Time frame: 2 hours post-dose

    Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.

  6. Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose

    Time frame: 2 hours post-dose

    Level of functional disability was assessed on a paper diary by the participants.

    Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 15, 2007
Registry last updated
Apr 22, 2024

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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