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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00246337
First received: October 27, 2005
Last updated: March 11, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: Comparator: Placebo
Drug: MK0974
Drug: Rizatriptan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pain Relief at 2 Hours [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Pain Freedom at 2 Hours [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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.

  • Sustained Pain Relief [ Time Frame: 2-24 hours post dose ] [ Designated as safety issue: No ]
    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.

  • Sustained Pain Freedom [ Time Frame: 2-24 hours post dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 420
Study Start Date: November 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
Drug: Comparator: Placebo
Placebo to match assigned treatment arm; one orally-administered dose
Experimental: MK0974 25 mg
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: MK0974
MK0974 25 mg; one orally-administered dose
Other Name: MK0974
Experimental: MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: MK0974
MK0974 50 mg; one orally-administered dose
Other Name: MK0974
Experimental: MK0974 100 mg
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: MK0974
MK0974 100 mg; one orally-administered dose
Other Name: MK0974
Experimental: MK0974 200 mg
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: MK0974
MK0974 200 mg; one orally-administered dose
Other Name: MK0974
Experimental: MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: MK0974
MK0974 300 mg; one orally-administered dose
Other Name: MK0974
Experimental: MK0974 400 mg
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: MK0974
MK0974 400 mg; one orally-administered dose
Other Name: MK0974
Experimental: MK0974 600 mg
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: MK0974
MK0974 600 mg; one orally-administered dose
Other Name: MK0974
Active Comparator: Rizatriptan 10 mg
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Drug: Rizatriptan
Rizatriptan 10 mg; one orally-administered dose
Other Name: Rizatriptan

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246337

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00246337     History of Changes
Other Study ID Numbers: MK-0974-004, 2005_082
Study First Received: October 27, 2005
Results First Received: July 19, 2010
Last Updated: March 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014