A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
October 30, 2015 updated by: Merck Sharp & Dohme LLC
A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
420
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
MK0974 25 mg; one orally-administered dose
MK0974 50 mg; one orally-administered dose
MK0974 100 mg; one orally-administered dose
MK0974 200 mg; one orally-administered dose
MK0974 300 mg; one orally-administered dose
MK0974 400 mg; one orally-administered dose
MK0974 600 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.
|
MK0974 25 mg; one orally-administered dose
MK0974 50 mg; one orally-administered dose
MK0974 100 mg; one orally-administered dose
MK0974 200 mg; one orally-administered dose
MK0974 300 mg; one orally-administered dose
MK0974 400 mg; one orally-administered dose
MK0974 600 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.
|
MK0974 25 mg; one orally-administered dose
MK0974 50 mg; one orally-administered dose
MK0974 100 mg; one orally-administered dose
MK0974 200 mg; one orally-administered dose
MK0974 300 mg; one orally-administered dose
MK0974 400 mg; one orally-administered dose
MK0974 600 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.
|
MK0974 25 mg; one orally-administered dose
MK0974 50 mg; one orally-administered dose
MK0974 100 mg; one orally-administered dose
MK0974 200 mg; one orally-administered dose
MK0974 300 mg; one orally-administered dose
MK0974 400 mg; one orally-administered dose
MK0974 600 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.
|
MK0974 25 mg; one orally-administered dose
MK0974 50 mg; one orally-administered dose
MK0974 100 mg; one orally-administered dose
MK0974 200 mg; one orally-administered dose
MK0974 300 mg; one orally-administered dose
MK0974 400 mg; one orally-administered dose
MK0974 600 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.
|
MK0974 25 mg; one orally-administered dose
MK0974 50 mg; one orally-administered dose
MK0974 100 mg; one orally-administered dose
MK0974 200 mg; one orally-administered dose
MK0974 300 mg; one orally-administered dose
MK0974 400 mg; one orally-administered dose
MK0974 600 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.
|
MK0974 25 mg; one orally-administered dose
MK0974 50 mg; one orally-administered dose
MK0974 100 mg; one orally-administered dose
MK0974 200 mg; one orally-administered dose
MK0974 300 mg; one orally-administered dose
MK0974 400 mg; one orally-administered dose
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.
|
Rizatriptan 10 mg; one orally-administered dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 hours post dose
|
|
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.
|
2-24 hours post dose
|
|
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.
|
2-24 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
October 27, 2005
First Submitted That Met QC Criteria
October 27, 2005
First Posted (Estimate)
October 30, 2005
Study Record Updates
Last Update Posted (Estimate)
November 1, 2015
Last Update Submitted That Met QC Criteria
October 30, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0974-004
- 2005_082
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