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Trial record 18 of 264 for:    Migraine AND Acute Migraine

A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)

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ClinicalTrials.gov Identifier: NCT01657370
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : December 9, 2016
Last Update Posted : December 9, 2016
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
Drug: Rescue medication
Enrollment 195
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 MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Period Title: Overall Study
Started 33 32 32 33 34 31
Completed 27 28 25 28 27 27
Not Completed 6 4 7 5 7 4
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             1
Physician Decision             2             3             1             2             5             0
Lack of Qualifying Event             1             0             3             2             1             2
Adverse Event             0             0             0             0             1             0
Protocol Violation             1             1             1             1             0             0
Lost to Follow-up             2             0             1             0             0             1
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 MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. Total of all reporting groups
Overall Number of Baseline Participants 28 28 26 28 28 27 165
Hide Baseline Analysis Population Description
All Subjects as Treated Population included all randomized participants who received at least 1 dose of study treatment.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 26 participants 28 participants 28 participants 27 participants 165 participants
<20 years 1 1 0 0 0 2 4
20 to 29 years 4 8 6 9 11 9 47
30 to 39 years 9 7 7 7 6 6 42
40 to 49 years 9 9 7 7 6 6 44
50 to 59 years 5 3 4 3 4 3 22
60 to 64 years 0 0 0 2 0 1 3
>= 65 years 0 0 2 0 1 0 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 26 participants 28 participants 28 participants 27 participants 165 participants
Female
25
  89.3%
26
  92.9%
22
  84.6%
23
  82.1%
26
  92.9%
18
  66.7%
140
  84.8%
Male
3
  10.7%
2
   7.1%
4
  15.4%
5
  17.9%
2
   7.1%
9
  33.3%
25
  15.2%
1.Primary Outcome
Title Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day
Hide Description The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay.
Time Frame 2 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis.
Arm/Group Title MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 21 23 27 22 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomolar (nM)
1.9
(73%)
17.0
(74%)
43.8
(130%)
52.7
(270%)
184.8
(170%)
2.Primary Outcome
Title Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day
Time Frame 2 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 12.3)
0.0
(0.0 to 12.3)
3.8
(0.1 to 19.6)
17.9
(6.1 to 36.9)
28.6
(13.2 to 48.7)
11.1
(2.4 to 29.2)
3.Primary Outcome
Title Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day
Time Frame 2 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.9
(24.5 to 62.8)
42.9
(24.5 to 62.8)
30.8
(14.3 to 51.8)
46.4
(27.5 to 66.1)
67.9
(47.6 to 84.1)
70.4
(49.8 to 86.2)
4.Secondary Outcome
Title Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day
Hide Description Phonophobia is sensitivity to sound.
Time Frame 2 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.6
(13.2 to 48.7)
42.9
(24.5 to 62.8)
30.8
(14.3 to 51.8)
42.9
(24.5 to 62.8)
57.1
(37.2 to 75.5)
44.4
(25.5 to 64.7)
5.Secondary Outcome
Title Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day
Hide Description Photophobia is sensitivity to light.
Time Frame 2 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(10.7 to 44.9)
25.0
(10.7 to 44.9)
26.9
(11.6 to 47.8)
28.6
(13.2 to 48.7)
46.4
(27.5 to 66.1)
48.1
(28.7 to 68.1)
6.Secondary Outcome
Title Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day
Hide Description [Not Specified]
Time Frame 2 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.9
(47.6 to 84.1)
57.1
(37.2 to 75.5)
69.2
(48.2 to 85.7)
57.1
(37.2 to 75.5)
82.1
(63.1 to 93.9)
74.1
(53.7 to 88.9)
7.Secondary Outcome
Title Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day
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 2-24 hour period after dosing with study medication.
Time Frame 2-24 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 12.3)
0.0
(0.0 to 12.3)
3.8
(0.1 to 19.6)
10.7
(2.3 to 28.2)
14.3
(4.0 to 32.7)
3.7
(0.1 to 19.0)
8.Secondary Outcome
Title Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day
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 2-24 hour period after dosing with study medication.
Time Frame 2-24 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.6
(13.2 to 48.7)
25.0
(10.7 to 44.9)
15.4
(4.4 to 34.9)
42.9
(24.5 to 62.8)
57.1
(37.2 to 75.5)
48.1
(28.7 to 68.1)
9.Secondary Outcome
Title Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day
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 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 12.3)
0.0
(0.0 to 12.3)
0.0
(0.0 to 13.2)
14.3
(4.0 to 32.7)
28.6
(13.2 to 48.7)
7.4
(0.9 to 24.3)
10.Secondary Outcome
Title Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day
Hide Description TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication.
Time Frame 2-24 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.
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:
MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 28 28 26 28 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 12.3)
0.0
(0.0 to 12.3)
0.0
(0.0 to 13.2)
10.7
(2.3 to 28.2)
14.3
(4.0 to 32.7)
3.7
(0.1 to 19.0)
11.Other Pre-specified Outcome
Title Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day
Hide Description [Not Specified]
Time Frame Up to 24 hours post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
As per protocol, only listings of individual DBS for MK-1602 over time were produced. No formal non-compartmental Pharmacokinetic (PK) analysis was done for this outcome measure.
Arm/Group Title MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Other Pre-specified Outcome
Title Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)
Hide Description [Not Specified]
Time Frame 3.5 hours post dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
As per protocol, only listings of individual DBS concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.
Arm/Group Title MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Other Pre-specified Outcome
Title Plasma MK-1602 Concentrations at Visit 2 (Day 4)
Hide Description [Not Specified]
Time Frame Up to 3.5 hours post dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
As per protocol, only listings of individual plasma concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.
Arm/Group Title MK-1602 1 mg MK-1602 10 mg MK-1602 25 mg MK-1602 50 mg MK-1602 100 mg
Hide Arm/Group Description:
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
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 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 MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. 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   0/28 (0.00%)   0/28 (0.00%)   0/26 (0.00%)   0/28 (0.00%)   0/28 (0.00%)   0/27 (0.00%) 
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   6/28 (21.43%)   6/28 (21.43%)   2/26 (7.69%)   10/28 (35.71%)   7/28 (25.00%)   7/27 (25.93%) 
Gastrointestinal disorders             
Abdominal pain upper  1  0/28 (0.00%)  1/28 (3.57%)  0/26 (0.00%)  0/28 (0.00%)  2/28 (7.14%)  2/27 (7.41%) 
Diarrhoea  1  0/28 (0.00%)  0/28 (0.00%)  0/26 (0.00%)  2/28 (7.14%)  1/28 (3.57%)  0/27 (0.00%) 
Dry mouth  1  0/28 (0.00%)  1/28 (3.57%)  1/26 (3.85%)  2/28 (7.14%)  2/28 (7.14%)  1/27 (3.70%) 
Nausea  1  1/28 (3.57%)  0/28 (0.00%)  1/26 (3.85%)  2/28 (7.14%)  3/28 (10.71%)  1/27 (3.70%) 
General disorders             
Fatigue  1  1/28 (3.57%)  0/28 (0.00%)  0/26 (0.00%)  2/28 (7.14%)  0/28 (0.00%)  0/27 (0.00%) 
Infections and infestations             
Nasopharyngitis  1  1/28 (3.57%)  1/28 (3.57%)  0/26 (0.00%)  1/28 (3.57%)  0/28 (0.00%)  2/27 (7.41%) 
Nervous system disorders             
Dizziness  1  4/28 (14.29%)  2/28 (7.14%)  0/26 (0.00%)  2/28 (7.14%)  0/28 (0.00%)  2/27 (7.41%) 
Headache  1  0/28 (0.00%)  2/28 (7.14%)  0/26 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Oropharyngeal pain  1  0/28 (0.00%)  0/28 (0.00%)  0/26 (0.00%)  2/28 (7.14%)  0/28 (0.00%)  0/27 (0.00%) 
Indicates events were collected by 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: NCT01657370     History of Changes
Other Study ID Numbers: 1602-007
First Submitted: August 2, 2012
First Posted: August 6, 2012
Results First Submitted: August 8, 2016
Results First Posted: December 9, 2016
Last Update Posted: December 9, 2016