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Completed

NCT Number: NCT00246337

A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

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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

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has at least 1 year history of migraine (with or without aura)
  • Females of childbearing years must use acceptable contraception throughout trial
  • Patient is in general good health based on screening assessment

Exclusion criteria

  • Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
  • Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease
  • Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)
  • Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
  • Patient has a history of cancer within the last 5 years

Treatment and study plan

Comparator: placebo

Drug

Placebo to match assigned treatment arm; one orally-administered dose

MK0974

Drug

MK0974 25 mg; one orally-administered dose

Rizatriptan

Drug

Rizatriptan 10 mg; one orally-administered dose

Primary outcomes

  1. Pain Relief at 2 Hours

    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), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.

Secondary outcomes

  1. Pain Freedom at 2 Hours

    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), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.

  2. Sustained Pain Relief

    Time frame: 2-24 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), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.

  3. Sustained Pain Freedom

    Time frame: 2-24 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), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 31, 2005
Registry last updated
Nov 2, 2015

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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