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OpenTrials
Completed

NCT Number: NCT00899379

Treatment of Multiple Attacks of Acute Migraine (0462-025)

A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

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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

Drug

Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache

Other names: MK0462

Comparator: placebo

Drug

Placebo to Rizatriptan, Oral Tablet

Primary outcomes

  1. Pain Relief at 2 Hours During the First Migraine Attack Period

    Time frame: 2 hours

    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack

Secondary outcomes

  1. Pain Relief at 2 Hours During the Second Migraine Attack Period

    Time frame: 2 hours

    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack

  2. Pain Relief at 2 Hours During the Third Migraine Attack Period

    Time frame: 2 hours

    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack

  3. Pain Relief at 2 Hours During the Fourth Migraine Attack Period

    Time frame: 2 hours

    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache

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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