Status:

COMPLETED

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

Lead Sponsor:

Organon and Co

Conditions:

Migraine Headache

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

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 whic...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 1995

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 1996

Estimated Enrollment :

1473 Patients enrolled

Trial Details

Trial ID

NCT00897949

Start Date

March 1 1995

End Date

July 1 1996

Last Update

February 3 2022

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