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A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)

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ClinicalTrials.gov Identifier: NCT01613248
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : September 30, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: MK-1602
Drug: Placebo-matching MK-1602
Drug: Rescue medication
Enrollment 834
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description 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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Period Title: Overall Study
Started 139 138 139 139 139 140
Completed 110 104 106 101 104 102
Not Completed 29 34 33 38 35 38
Reason Not Completed
Adverse Event             0             0             0             1             0             0
Withdrawal by Subject             3             2             2             5             0             1
Lost to Follow-up             5             7             4             8             4             2
Study Terminated by Sponsor             4             6             8             8             9             11
Physician Decision             8             8             9             4             7             6
Lack of Qualifying Event             9             11             10             11             15             18
Pregnancy             0             0             0             1             0             0
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg Total
Hide Arm/Group Description 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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. Total of all reporting groups
Overall Number of Baseline Participants 113 107 108 104 106 102 640
Hide Baseline Analysis Population Description
All Subjects as Treated Population included all randomized participants who received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 107 participants 108 participants 104 participants 106 participants 102 participants 640 participants
40.5  (11.7) 39.6  (10.7) 41.1  (10.9) 41.4  (11.5) 40.7  (12.3) 41.9  (11.0) 40.8  (11.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 107 participants 108 participants 104 participants 106 participants 102 participants 640 participants
< 20 years 1 1 0 2 2 0 6
20 to 29 years 18 21 19 13 19 16 106
30 to 39 years 42 29 28 32 32 26 189
40 to 49 years 22 36 42 33 23 33 189
50 to 59 years 19 17 14 16 21 23 110
60 to 64 years 10 2 5 8 9 3 37
>= 65 years 1 1 0 0 0 1 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 107 participants 108 participants 104 participants 106 participants 102 participants 640 participants
Female
99
  87.6%
95
  88.8%
92
  85.2%
91
  87.5%
92
  86.8%
90
  88.2%
559
  87.3%
Male
14
  12.4%
12
  11.2%
16
  14.8%
13
  12.5%
14
  13.2%
12
  11.8%
81
  12.7%
1.Primary Outcome
Title Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose
Hide Description 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.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 112 107 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.9
(4.4 to 15.8)
5.6
(2.1 to 11.8)
14.8
(8.7 to 22.9)
21.4
(13.9 to 30.5)
21.0
(13.6 to 30.0)
25.5
(17.4 to 35.1)
2.Primary Outcome
Title Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 112 107 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.6
(35.2 to 54.3)
37.4
(28.2 to 47.3)
52.8
(42.9 to 62.5)
53.4
(43.3 to 63.3)
57.1
(47.1 to 66.8)
58.8
(48.6 to 68.5)
3.Primary Outcome
Title Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose
Hide Description 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.
Time Frame Up to 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 103 107 102
Measure Type: Number
Unit of Measure: participants
28 33 29 21 23 30
4.Primary Outcome
Title Number of Participants With One or More Adverse Events Within 14 Days Post-Dose
Hide Description 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.
Time Frame Up to 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ASaT population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 103 107 102
Measure Type: Number
Unit of Measure: participants
33 37 32 24 30 32
5.Primary Outcome
Title Number of Participants Who Discontinued From Study Due to Adverse Events
Hide Description [Not Specified]
Time Frame Up to 5 weeks post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ASaT population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 104 106 102
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0
6.Secondary Outcome
Title Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose
Hide Description Phonophobia is sensitivity to loud sounds.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 112 107 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.0
(32.7 to 51.7)
45.8
(36.1 to 55.7)
49.1
(39.3 to 58.9)
55.3
(45.2 to 65.1)
56.2
(46.2 to 65.9)
60.8
(50.6 to 70.3)
7.Secondary Outcome
Title Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose
Hide Description Photophobia is sensitivity to bright light.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 112 107 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.4
(22.0 to 39.8)
37.4
(28.2 to 47.3)
43.5
(34.0 to 53.4)
39.8
(30.3 to 49.9)
47.6
(37.8 to 57.6)
54.9
(44.7 to 64.8)
8.Secondary Outcome
Title Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose
Hide Description [Not Specified]
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 112 107 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.5
(52.9 to 71.5)
59.8
(49.9 to 69.2)
67.6
(57.9 to 76.3)
73.8
(64.2 to 82.0)
68.6
(58.8 to 77.3)
70.6
(60.7 to 79.2)
9.Secondary Outcome
Title Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose
Hide Description 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.
Time Frame 2-24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 103 106 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.2
(2.5 to 12.3)
4.7
(1.5 to 10.6)
9.3
(4.5 to 16.4)
14.6
(8.4 to 22.9)
15.1
(8.9 to 23.4)
21.6
(14.0 to 30.8)
10.Secondary Outcome
Title Percentage of Participants Reporting SPF 2-48 Hours Post-Dose
Hide Description 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.
Time Frame 2-48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 103 106 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.2
(2.5 to 12.3)
4.7
(1.5 to 10.6)
9.3
(4.5 to 16.4)
14.6
(8.4 to 22.9)
14.2
(8.1 to 22.3)
20.6
(13.2 to 29.7)
11.Secondary Outcome
Title Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose
Hide Description 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.
Time Frame 2-24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.3
(20.2 to 37.6)
17.8
(11.0 to 26.3)
36.1
(27.1 to 45.9)
39.8
(30.3 to 49.9)
45.7
(36.0 to 55.7)
46.1
(36.2 to 56.2)
12.Secondary Outcome
Title Percentage of Participants Reporting SPR 2-48 Hours Post-Dose
Hide Description 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.
Time Frame 2-48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 112 106 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(17.3 to 34.1)
17.0
(10.4 to 25.5)
32.4
(23.7 to 42.1)
37.9
(28.5 to 48.0)
42.9
(33.2 to 52.9)
43.1
(33.4 to 53.3)
13.Secondary Outcome
Title Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose
Hide Description TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 112 107 108 103 105 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.0
(3.7 to 14.7)
5.6
(2.1 to 11.8)
13.9
(8.0 to 21.9)
20.4
(13.1 to 29.5)
20.0
(12.8 to 28.9)
23.5
(15.7 to 33.0)
14.Secondary Outcome
Title Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose
Hide Description 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.
Time Frame 2-24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 103 106 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.3
(2.0 to 11.2)
4.7
(1.5 to 10.6)
9.3
(4.5 to 16.4)
12.6
(6.9 to 20.6)
14.2
(8.1 to 22.3)
20.6
(13.2 to 29.7)
15.Secondary Outcome
Title Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose
Hide Description 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.
Time Frame 2-48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 113 107 108 103 106 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.3
(2.0 to 11.2)
4.7
(1.5 to 10.6)
9.3
(4.5 to 16.4)
12.6
(6.9 to 20.6)
13.2
(7.4 to 21.2)
19.6
(12.4 to 28.6)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description 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 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 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 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 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 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
All-Cause Mortality
Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/113 (0.00%)   0/107 (0.00%)   0/108 (0.00%)   0/104 (0.00%)   1/106 (0.94%)   0/102 (0.00%) 
Nervous system disorders             
Myoclonus  1 [1]  0/113 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/102 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
SAE: Myoclonus occurred 15 days post-dose.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/113 (13.27%)   22/107 (20.56%)   13/108 (12.04%)   15/104 (14.42%)   14/106 (13.21%)   17/102 (16.67%) 
Gastrointestinal disorders             
Dry mouth * 1  4/113 (3.54%)  8/107 (7.48%)  2/108 (1.85%)  3/104 (2.88%)  4/106 (3.77%)  5/102 (4.90%) 
Nausea * 1  4/113 (3.54%)  7/107 (6.54%)  4/108 (3.70%)  6/104 (5.77%)  8/106 (7.55%)  7/102 (6.86%) 
Nervous system disorders             
Dizziness * 1  1/113 (0.88%)  8/107 (7.48%)  5/108 (4.63%)  3/104 (2.88%)  2/106 (1.89%)  6/102 (5.88%) 
Somnolence * 1  6/113 (5.31%)  5/107 (4.67%)  4/108 (3.70%)  5/104 (4.81%)  3/106 (2.83%)  4/102 (3.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01613248     History of Changes
Other Study ID Numbers: 1602-006
First Submitted: May 16, 2012
First Posted: June 7, 2012
Results First Submitted: August 8, 2016
Results First Posted: September 30, 2016
Last Update Posted: January 8, 2019