Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: 10.1177/0333102411398399. Epub 2011 Mar 7.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Participants were assessed using the protocol inclusion and exclusion criteria at Visit 1 and, if eligible, were randomized at the same visit.
Recruitment Details
Participants were recruited from 47 neurological and general research centers worldwide (19 in the United States and 28 internationally). The primary therapy period was between 2-Jul-08 to 16-Jan-09.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
FG001
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
FG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
FG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
FG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
FG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
FG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
FG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000169 subjects
FG00139 subjects
FG00257 subjects
FG00384 subjects
FG00486 subjects
FG00584 subjects
FG00683 subjects
FG00774 subjects
COMPLETED
FG000140 subjectsThe "Not Completed" patients discontinued prior to receiving study medication.
FG00133 subjectsThe "Not Completed" patients discontinued prior to receiving study medication.
FG00247 subjectsThe "Not Completed" patients discontinued prior to receiving study medication.
FG003
NOT COMPLETED
FG00029 subjects
FG0016 subjects
FG00210 subjects
FG00317 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG001
MK3207 2.5 mg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Pain Freedom (PF)
Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.
Rating of Headache Severity (Scale from Grade 0 to 3):
Grade 0: No pain
Grade 1: Mild pain
Grade 2: Moderate pain
Grade 3: Severe pain
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Posted
Number
Participants
2 hours postdose
ID
Title
Description
OG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG001
MK3207 2.5 mg
Adverse Events Module
Frequency Threshold
2
Time Frame
Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Description
Every patient is counted a single time for each applicable specific adverse event.
Patients in population are patients who took at least one tablet of the study medication.
Placebo is the pooled arm of all matching placebo doses.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MedDRA (11.1)
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA (11.1)
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
2 hours postdose
Absence of Phonophobia
Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
2 hours postdose
Absence of Nausea
Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
2 hours postdose
Sustained Pain Freedom (SPF)
Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.
2-24 hours postdose
67 subjects
The "Not Completed" patients discontinued prior to receiving study medication.
FG00467 subjectsThe "Not Completed" patients discontinued prior to receiving study medication.
FG00568 subjectsThe "Not Completed" patients discontinued prior to receiving study medication.
FG00661 subjectsOne patient received study drug. The remaining patients discontinued prior to receiving study drug.
FG00763 subjectsThe "Not Completed" patients discontinued prior to receiving study medication.
19 subjects
FG00516 subjects
FG00622 subjects
FG00711 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0052 subjects
FG0063 subjects
FG0071 subjects
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
Lack of Qualifying Event
FG00016 subjects
FG0012 subjects
FG0026 subjects
FG0038 subjects
FG00411 subjects
FG00513 subjects
FG00611 subjects
FG0076 subjects
Protocol Specified Criteria
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
BG008
Total
Total of all reporting groups
140
BG00133
BG00247
BG00367
BG00467
BG00568
BG00662
BG00763
BG008547
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.1± 11.2
BG00143.3± 10.5
BG00243.4± 11.1
BG00344.1± 10.0
BG00444.1± 11.3
BG00542.2± 10.8
BG00642.2± 10.9
BG00740.5± 10.7
BG00842.7± 10.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000125
BG00127
BG00240
BG00362
BG00454
BG00562
BG00652
BG00754
BG008476
Male
BG00015
BG0016
BG0027
BG0035
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00015
BG0014
BG0024
BG0034
BG00410
BG00513
BG0069
BG00710
BG00869
Not Hispanic or Latino
BG000125
BG00129
BG00243
BG00363
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG000132
BG00132
BG00246
BG00362
BG00463
BG00564
BG00659
BG00759
BG008517
Black
Title
Measurements
BG0005
BG0010
BG0021
BG003
Asian
Title
Measurements
BG0001
BG0011
BG0020
BG003
American Indian or Alaska Native
Title
Measurements
BG0001
BG0010
BG0020
BG003
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG003
Multi-Racial
Title
Measurements
BG0001
BG0010
BG0020
BG003
Study Region
Number
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00066
BG00114
BG00222
BG00330
BG00439
BG00545
BG00634
BG00720
BG008270
Ex-United States
Title
Measurements
BG00074
BG00119
BG00225
BG003
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Units
Counts
Participants
OG000133
OG00132
OG00244
OG00363
OG00463
OG00565
OG00659
OG00758
Title
Denominators
Categories
Title
Measurements
OG00013
OG0014
OG0025
OG00316
OG00412
OG00514
OG00614
OG00721
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Generalized linear regression model
Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
<0.001
p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.
95
No
Superiority or Other
Secondary
Pain Relief (PR)
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.
Rating of Headache Severity (Scale from Grade 0 to 3):
Grade 0: No pain
Grade 1: Mild pain
Grade 2: Moderate pain
Grade 3: Severe pain
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Posted
Number
Participants
2 hours postdose
ID
Title
Description
OG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG001
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Units
Counts
Participants
OG000133
OG00132
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG00048
OG00115
OG00219
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Generalized linear regression model
Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
<0.001
p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.
95
No
Superiority or Other
Secondary
Absence of Photophobia
Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Posted
Number
Participants
2 hours postdose
ID
Title
Description
OG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG001
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Units
Counts
Participants
OG000133
OG00132
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG00051
OG00110
OG00215
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Generalized linear regression model
Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
<0.001
p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.
95
No
Superiority or Other
Secondary
Absence of Phonophobia
Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Posted
Number
Participants
2 hours postdose
ID
Title
Description
OG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG001
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Units
Counts
Participants
OG000133
OG00132
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG00057
OG00112
OG00218
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Generalized linear regression model
Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
<0.001
p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.
95
No
Superiority or Other
Secondary
Absence of Nausea
Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Posted
Number
Participants
2 hours postdose
ID
Title
Description
OG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG001
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Units
Counts
Participants
OG000133
OG00132
OG00243
OG003
Title
Denominators
Categories
Title
Measurements
OG00079
OG00119
OG00225
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Generalized linear regression model
Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
0.007
p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.
95
No
Superiority or Other
Secondary
Sustained Pain Freedom (SPF)
Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.
Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.
Posted
Number
Participants
2-24 hours postdose
ID
Title
Description
OG000
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG001
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
OG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Units
Counts
Participants
OG000133
OG00132
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG00010
OG0014
OG0022
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Generalized linear regression model
Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
<0.001
p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.
95
No
Superiority or Other
1
142
20
142
EG001
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
0
32
10
32
EG002
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
0
47
18
47
EG003
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1
66
9
66
EG004
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
0
67
14
67
EG005
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
0
68
16
68
EG006
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
0
62
17
62
EG007
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
0
63
11
63
EG0001 affected142 at risk
EG0010 affected32 at risk
EG0020 affected47 at risk
EG0030 affected0 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Hypersensitivity
Immune system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0010 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Ovarian cyst
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0020 affected47 at risk
EG0031 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0041 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Tachycardia
Cardiac disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0061 affected62 at risk
EG0070 affected63 at risk
Vertigo
Ear and labyrinth disorders
MedDRA (11.1)
Non-systematic Assessment
EG0002 affected142 at risk
EG0011 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0062 affected62 at risk
EG0070 affected63 at risk
Vision blurred
Eye disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0041 affected67 at risk
EG0050 affected68 at risk
EG0062 affected62 at risk
EG0070 affected63 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0002 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0032 affected66 at risk
EG0040 affected67 at risk
EG0051 affected68 at risk
EG0061 affected62 at risk
EG0070 affected63 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0002 affected142 at risk
EG0011 affected32 at risk
EG0021 affected47 at risk
EG0031 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0061 affected62 at risk
EG0070 affected63 at risk
Dry mouth
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0003 affected142 at risk
EG0010 affected32 at risk
EG0023 affected47 at risk
EG0031 affected66 at risk
EG0042 affected67 at risk
EG0054 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0051 affected68 at risk
EG0061 affected62 at risk
EG0070 affected63 at risk
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Nausea
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0005 affected142 at risk
EG0011 affected32 at risk
EG0022 affected47 at risk
EG0033 affected66 at risk
EG0045 affected67 at risk
EG0053 affected68 at risk
EG0065 affected62 at risk
EG0072 affected63 at risk
Paraesthesia oral
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Regurgitation
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Vomiting
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0023 affected47 at risk
EG0031 affected66 at risk
EG0041 affected67 at risk
EG0050 affected68 at risk
EG0061 affected62 at risk
EG0071 affected63 at risk
Chest discomfort
General disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Chills
General disorders
MedDRA (11.1)
Non-systematic Assessment
EG0002 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Fatigue
General disorders
MedDRA (11.1)
Non-systematic Assessment
EG0004 affected142 at risk
EG0011 affected32 at risk
EG0022 affected47 at risk
EG0032 affected66 at risk
EG0042 affected67 at risk
EG0054 affected68 at risk
EG0060 affected62 at risk
EG0072 affected63 at risk
Feeling hot
General disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0062 affected62 at risk
EG0070 affected63 at risk
Irritability
General disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0042 affected67 at risk
EG0050 affected68 at risk
EG0061 affected62 at risk
EG0070 affected63 at risk
Malaise
General disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Blood glucose increased
Investigations
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0051 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0063 affected62 at risk
EG0070 affected63 at risk
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Dizziness
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0002 affected142 at risk
EG0013 affected32 at risk
EG0024 affected47 at risk
EG0032 affected66 at risk
EG0042 affected67 at risk
EG0052 affected68 at risk
EG0061 affected62 at risk
EG0072 affected63 at risk
Dysgeusia
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0011 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0051 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Headache
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0012 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0041 affected67 at risk
EG0050 affected68 at risk
EG0063 affected62 at risk
EG0070 affected63 at risk
Hyperaesthesia
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Hypoaesthesia
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0052 affected68 at risk
EG0061 affected62 at risk
EG0071 affected63 at risk
Paraesthesia
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Somnolence
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0002 affected142 at risk
EG0011 affected32 at risk
EG0022 affected47 at risk
EG0030 affected66 at risk
EG0042 affected67 at risk
EG0053 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Tremor
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Aggression
Psychiatric disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Anxiety
Psychiatric disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Insomnia
Psychiatric disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0031 affected66 at risk
EG0040 affected67 at risk
EG0051 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Panic attack
Psychiatric disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0061 affected62 at risk
EG0070 affected63 at risk
Throat tightness
Respiratory, thoracic and mediastinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0022 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Yawning
Respiratory, thoracic and mediastinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0011 affected32 at risk
EG0020 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0041 affected67 at risk
EG0051 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0070 affected63 at risk
Flushing
Vascular disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 affected142 at risk
EG0010 affected32 at risk
EG0021 affected47 at risk
EG0030 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0071 affected63 at risk
Hot flush
Vascular disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 affected142 at risk
EG0010 affected32 at risk
EG0020 affected47 at risk
EG0031 affected66 at risk
EG0040 affected67 at risk
EG0050 affected68 at risk
EG0060 affected62 at risk
EG0072 affected63 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.