Trial Outcomes & Findings for A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006) (NCT NCT01613248)
NCT ID: NCT01613248
Last Updated: 2019-01-08
Results Overview
PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
834 participants
Primary outcome timeframe
2 hours post-dose
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
139
|
138
|
139
|
139
|
139
|
140
|
|
Overall Study
COMPLETED
|
110
|
104
|
106
|
101
|
104
|
102
|
|
Overall Study
NOT COMPLETED
|
29
|
34
|
33
|
38
|
35
|
38
|
Reasons for withdrawal
| Measure |
Placebo
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
5
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
4
|
8
|
4
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
6
|
8
|
8
|
9
|
11
|
|
Overall Study
Physician Decision
|
8
|
8
|
9
|
4
|
7
|
6
|
|
Overall Study
Lack of Qualifying Event
|
9
|
11
|
10
|
11
|
15
|
18
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)
Baseline characteristics by cohort
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=104 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
Total
n=640 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
40.7 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
41.9 years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
40.8 years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
|
Age, Customized
< 20 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
6 participants
n=8 Participants
|
|
Age, Customized
20 to 29 years
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
19 participants
n=5 Participants
|
13 participants
n=4 Participants
|
19 participants
n=21 Participants
|
16 participants
n=8 Participants
|
106 participants
n=8 Participants
|
|
Age, Customized
30 to 39 years
|
42 participants
n=5 Participants
|
29 participants
n=7 Participants
|
28 participants
n=5 Participants
|
32 participants
n=4 Participants
|
32 participants
n=21 Participants
|
26 participants
n=8 Participants
|
189 participants
n=8 Participants
|
|
Age, Customized
40 to 49 years
|
22 participants
n=5 Participants
|
36 participants
n=7 Participants
|
42 participants
n=5 Participants
|
33 participants
n=4 Participants
|
23 participants
n=21 Participants
|
33 participants
n=8 Participants
|
189 participants
n=8 Participants
|
|
Age, Customized
50 to 59 years
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
14 participants
n=5 Participants
|
16 participants
n=4 Participants
|
21 participants
n=21 Participants
|
23 participants
n=8 Participants
|
110 participants
n=8 Participants
|
|
Age, Customized
60 to 64 years
|
10 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
8 participants
n=4 Participants
|
9 participants
n=21 Participants
|
3 participants
n=8 Participants
|
37 participants
n=8 Participants
|
|
Age, Customized
>= 65 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
90 Participants
n=8 Participants
|
559 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
81 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose
|
8.9 percentage of participants
Interval 4.4 to 15.8
|
5.6 percentage of participants
Interval 2.1 to 11.8
|
14.8 percentage of participants
Interval 8.7 to 22.9
|
21.4 percentage of participants
Interval 13.9 to 30.5
|
21.0 percentage of participants
Interval 13.6 to 30.0
|
25.5 percentage of participants
Interval 17.4 to 35.1
|
PRIMARY outcome
Timeframe: 2 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose
|
44.6 percentage of participants
Interval 35.2 to 54.3
|
37.4 percentage of participants
Interval 28.2 to 47.3
|
52.8 percentage of participants
Interval 42.9 to 62.5
|
53.4 percentage of participants
Interval 43.3 to 63.3
|
57.1 percentage of participants
Interval 47.1 to 66.8
|
58.8 percentage of participants
Interval 48.6 to 68.5
|
PRIMARY outcome
Timeframe: Up to 48 hours post-dosePopulation: All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment.
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=107 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose
|
28 participants
|
33 participants
|
29 participants
|
21 participants
|
23 participants
|
30 participants
|
PRIMARY outcome
Timeframe: Up to 14 days post-dosePopulation: ASaT population included all randomized participants who received at least one dose of study treatment.
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=107 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Adverse Events Within 14 Days Post-Dose
|
33 participants
|
37 participants
|
32 participants
|
24 participants
|
30 participants
|
32 participants
|
PRIMARY outcome
Timeframe: Up to 5 weeks post-dosePopulation: ASaT population included all randomized participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=104 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued From Study Due to Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
Phonophobia is sensitivity to loud sounds.
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose
|
42.0 percentage of participants
Interval 32.7 to 51.7
|
45.8 percentage of participants
Interval 36.1 to 55.7
|
49.1 percentage of participants
Interval 39.3 to 58.9
|
55.3 percentage of participants
Interval 45.2 to 65.1
|
56.2 percentage of participants
Interval 46.2 to 65.9
|
60.8 percentage of participants
Interval 50.6 to 70.3
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
Photophobia is sensitivity to bright light.
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose
|
30.4 percentage of participants
Interval 22.0 to 39.8
|
37.4 percentage of participants
Interval 28.2 to 47.3
|
43.5 percentage of participants
Interval 34.0 to 53.4
|
39.8 percentage of participants
Interval 30.3 to 49.9
|
47.6 percentage of participants
Interval 37.8 to 57.6
|
54.9 percentage of participants
Interval 44.7 to 64.8
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose
|
62.5 percentage of participants
Interval 52.9 to 71.5
|
59.8 percentage of participants
Interval 49.9 to 69.2
|
67.6 percentage of participants
Interval 57.9 to 76.3
|
73.8 percentage of participants
Interval 64.2 to 82.0
|
68.6 percentage of participants
Interval 58.8 to 77.3
|
70.6 percentage of participants
Interval 60.7 to 79.2
|
SECONDARY outcome
Timeframe: 2-24 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose
|
6.2 percentage of participants
Interval 2.5 to 12.3
|
4.7 percentage of participants
Interval 1.5 to 10.6
|
9.3 percentage of participants
Interval 4.5 to 16.4
|
14.6 percentage of participants
Interval 8.4 to 22.9
|
15.1 percentage of participants
Interval 8.9 to 23.4
|
21.6 percentage of participants
Interval 14.0 to 30.8
|
SECONDARY outcome
Timeframe: 2-48 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting SPF 2-48 Hours Post-Dose
|
6.2 percentage of participants
Interval 2.5 to 12.3
|
4.7 percentage of participants
Interval 1.5 to 10.6
|
9.3 percentage of participants
Interval 4.5 to 16.4
|
14.6 percentage of participants
Interval 8.4 to 22.9
|
14.2 percentage of participants
Interval 8.1 to 22.3
|
20.6 percentage of participants
Interval 13.2 to 29.7
|
SECONDARY outcome
Timeframe: 2-24 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose
|
28.3 percentage of participants
Interval 20.2 to 37.6
|
17.8 percentage of participants
Interval 11.0 to 26.3
|
36.1 percentage of participants
Interval 27.1 to 45.9
|
39.8 percentage of participants
Interval 30.3 to 49.9
|
45.7 percentage of participants
Interval 36.0 to 55.7
|
46.1 percentage of participants
Interval 36.2 to 56.2
|
SECONDARY outcome
Timeframe: 2-48 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication.
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=106 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting SPR 2-48 Hours Post-Dose
|
25.0 percentage of participants
Interval 17.3 to 34.1
|
17.0 percentage of participants
Interval 10.4 to 25.5
|
32.4 percentage of participants
Interval 23.7 to 42.1
|
37.9 percentage of participants
Interval 28.5 to 48.0
|
42.9 percentage of participants
Interval 33.2 to 52.9
|
43.1 percentage of participants
Interval 33.4 to 53.3
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=105 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose
|
8.0 percentage of participants
Interval 3.7 to 14.7
|
5.6 percentage of participants
Interval 2.1 to 11.8
|
13.9 percentage of participants
Interval 8.0 to 21.9
|
20.4 percentage of participants
Interval 13.1 to 29.5
|
20.0 percentage of participants
Interval 12.8 to 28.9
|
23.5 percentage of participants
Interval 15.7 to 33.0
|
SECONDARY outcome
Timeframe: 2-24 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose
|
5.3 percentage of participants
Interval 2.0 to 11.2
|
4.7 percentage of participants
Interval 1.5 to 10.6
|
9.3 percentage of participants
Interval 4.5 to 16.4
|
12.6 percentage of participants
Interval 6.9 to 20.6
|
14.2 percentage of participants
Interval 8.1 to 22.3
|
20.6 percentage of participants
Interval 13.2 to 29.7
|
SECONDARY outcome
Timeframe: 2-48 hours post-dosePopulation: Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.
TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 Participants
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 Participants
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=103 Participants
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 Participants
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 Participants
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose
|
5.3 percentage of participants
Interval 2.0 to 11.2
|
4.7 percentage of participants
Interval 1.5 to 10.6
|
9.3 percentage of participants
Interval 4.5 to 16.4
|
12.6 percentage of participants
Interval 6.9 to 20.6
|
13.2 percentage of participants
Interval 7.4 to 21.2
|
19.6 percentage of participants
Interval 12.4 to 28.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
MK-1602 1 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
MK-1602 10 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
MK-1602 25 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
MK-1602 50 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
MK-1602 100 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=113 participants at risk
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 participants at risk
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 participants at risk
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=104 participants at risk
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 participants at risk
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 participants at risk
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Myoclonus
|
0.00%
0/113
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
0.00%
0/107
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
0.00%
0/108
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
0.00%
0/104
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
0.94%
1/106
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
0.00%
0/102
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
Other adverse events
| Measure |
Placebo
n=113 participants at risk
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 1 mg
n=107 participants at risk
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 10 mg
n=108 participants at risk
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 25 mg
n=104 participants at risk
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 50 mg
n=106 participants at risk
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
MK-1602 100 mg
n=102 participants at risk
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
3.5%
4/113
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
7.5%
8/107
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
1.9%
2/108
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
2.9%
3/104
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
3.8%
4/106
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
4.9%
5/102
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
4/113
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
6.5%
7/107
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
3.7%
4/108
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
5.8%
6/104
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
7.5%
8/106
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
6.9%
7/102
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
|
Nervous system disorders
Dizziness
|
0.88%
1/113
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
7.5%
8/107
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
4.6%
5/108
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
2.9%
3/104
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
1.9%
2/106
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
5.9%
6/102
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
|
Nervous system disorders
Somnolence
|
5.3%
6/113
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
4.7%
5/107
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
3.7%
4/108
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
4.8%
5/104
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
2.8%
3/106
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
3.9%
4/102
All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER