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Completed

NCT Number: NCT00897949

MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo.

The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.

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Key information

Conditions

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

  • Patient had at least a 6-month history of migraine, with or without aura
  • Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
  • Patient was judged to be in good health, apart from migraine

Exclusion criteria

  • Patient was pregnant or a nursing mother
  • Patient had abused drugs or alcohol within 12 months prior to entering the study
  • Patient had a history of cardiovascular disease
  • Patient had clinically significant ECG abnormality
  • Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
  • Patient received treatment with an investigational device or compound within 30 days of the study start
  • Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
  • Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
  • Patient had prior exposure to rizatriptan

Treatment and study plan

rizatriptan benzoate (MK0462)

Drug

Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.

Comparator: placebo

Drug

Placebo to rizatriptan

Primary outcomes

  1. Pain Relief at 2 Hours After the Initial Dose of Test Drug

    Time frame: 2 hours after initial dose of test drug

    Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.

Secondary outcomes

  1. Pain Free at 2 Hours After the Initial Dose of Test Drug

    Time frame: 2 hours after initial dose of test drug

    Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.

  2. No Disability at 2 Hours After the Initial Dose of Test Drug

    Time frame: 2 hours after initial dose of test drug

    Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 - Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest

  3. Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug

    Time frame: 2 hours after initial dose of test drug

  4. Pain Relief 2 Hours After Treatment for Headache Recurrence

    Time frame: 2 hours after treatment for recurrence

    Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Triple-Blind, Double-Dummy, Placebo-Controlled, Parallel Groups, Outpatient Study to Examine the Safety and Efficacy of MK0462 10 mg p.o. and MK0462 5 mg p.o. for the Treatment of Acute Migraine and Migraine Recurrence

Important dates

Study start
1995
Primary completion
1996
Study completion
1996
First posted
May 12, 2009
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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