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

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ClinicalTrials.gov Identifier: NCT00246337
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : September 15, 2010
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Drug: Comparator: Placebo Drug: MK0974 Drug: Rizatriptan Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
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
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
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
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
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
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
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
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246337


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00246337     History of Changes
Other Study ID Numbers: 0974-004
2005_082
First Posted: October 31, 2005    Key Record Dates
Results First Posted: September 15, 2010
Last Update Posted: November 2, 2015
Last Verified: October 2015

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
Physiological Effects of Drugs