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Completed

NCT Number: NCT00095004

Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.

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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

  • Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.

Exclusion criteria

  • Heart disease
  • High blood pressure

Treatment and study plan

MK0462, rizatriptan benzoate / Duration of Treatment: 1day

Drug

Comparator: placebo / Duration of Treatment: 1 day

Drug

Primary outcomes

  1. Percentage of patients who are pain free at 2 hours postdose

  2. Tolerability as measured by subjective adverse experience reporting

Secondary outcomes

  1. Percentage of patients with 24 hour sustained pain freedom

  2. Percentage of patients pain free at 30/45/60/90 minutes post dose

  3. Percentage of patients with associated symptoms at 2 hours

  4. Percentage of patients requiring rescue medication between 2 & 24 hours

  5. Percentage of patients with functional disability at 2 hours

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 1, 2004
Registry last updated
Aug 14, 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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