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Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00432237
Recruitment Status : Completed
First Posted : February 7, 2007
Results First Posted : December 6, 2010
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: MK0974 50 mg
Drug: MK0974 150 mg
Drug: MK0974 300 mg
Drug: Comparator: Placebo
Enrollment 1703
Recruitment Details There were 83 centers worldwide that participated: United States (36), Latin America (9), and Europe (38). First Patient Treated = 25 March 2007, and Last Patient Last Treatment = 29 November 2007.
Pre-assignment Details Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Period Title: Overall Study
Started 244 [1] 485 484 [2] 490
Completed--With Data 176 381 370 365
Completed--No Data 1 [3] 3 [3] 5 [3] 1 [3]
Completed 177 384 375 366
Not Completed 67 101 109 124
Reason Not Completed
Adverse Event             0             0             0             1
Lack of Efficacy             0             0             0             1
Lost to Follow-up             10             10             18             18
Physician Decision             1             3             2             1
Pregnancy             0             1             0             0
Protocol Violation             13             10             11             8
Withdrawal by Subject             5             6             9             11
Lack of Qualifying Event             38             71             69             84
[1]
1 patient in the MK0974 50 mg group was treated but withdrew consent.
[2]
1 patient in the MK0974 300 mg group was treated but withdrew consent.
[3]
For patients in this category, diaries were collected but lost prior to data entry.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo Total
Hide Arm/Group Description

MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack

The reported number of participants are all patients randomized who received study drug and completed the study.

Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack

The reported number of participants are all patients randomized who received study drug and completed the study.

Total of all reporting groups
Overall Number of Baseline Participants 177 381 371 365 1294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 381 participants 371 participants 365 participants 1294 participants
41.4  (11.3) 41.6  (11.0) 41.8  (11.6) 41.9  (11.9) 41.7  (11.5)
[1]
Measure Description: Baseline Characteristics are for the subset of randomized patients who were treated
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 381 participants 371 participants 365 participants 1294 participants
Female
156
  88.1%
329
  86.4%
320
  86.3%
318
  87.1%
1123
  86.8%
Male
21
  11.9%
52
  13.6%
51
  13.7%
47
  12.9%
171
  13.2%
[1]
Measure Description: Baseline Characteristics are for the subset of randomized patients who were treated
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 381 participants 371 participants 365 participants 1294 participants
White 148 320 302 303 1073
Black 10 16 23 20 69
Asian 1 6 1 8 16
American Indian or Alaska Native 1 2 0 0 3
Native Hawaiian or Other Pacific Islander 0 0 1 0 1
Multi-Racial 17 37 44 33 131
Missing 0 0 0 1 1
[1]
Measure Description: Baseline Characteristics are for the subset of randomized patients who were treated
Baseline Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 381 participants 371 participants 365 participants 1294 participants
Moderate 108 254 237 235 834
Severe 69 127 133 130 459
Baseline Severity missing 0 0 1 0 1
[1]
Measure Description: Baseline severity was self-reported by the patient and recorded in the take-home diary. Patients were instructed not to dose until they had experienced either a moderate or severe migraine, with migraine pain rated on a 4-point scale (No Pain=0, Mild Pain=1, Moderate Pain=2, Severe Pain=3). Baseline Characteristics are for the subset of randomized patients who were treated.
1.Primary Outcome
Title Number of Patients Reporting Pain Freedom at 2 Hours Postdose
Hide Description

Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.

Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 176 380 369 365
Measure Type: Number
Unit of Measure: Participants
29 88 88 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
2.Primary Outcome
Title Number of Patients Reporting Pain Relief at 2 Hours Post Dose
Hide Description

Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.

Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 176 380 369 365
Measure Type: Number
Unit of Measure: Participants
78 205 205 120
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
3.Primary Outcome
Title Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
Hide Description Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 176 380 369 365
Measure Type: Number
Unit of Measure: Participants
72 176 179 119
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
4.Primary Outcome
Title Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
Hide Description Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 176 380 369 365
Measure Type: Number
Unit of Measure: Participants
85 192 206 152
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
5.Primary Outcome
Title Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
Hide Description Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 176 380 369 365
Measure Type: Number
Unit of Measure: Participants
113 260 258 196
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
6.Secondary Outcome
Title Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose
Hide Description Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.
Time Frame 2 to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 177 378 365 363
Measure Type: Number
Unit of Measure: Participants
25 62 63 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
7.Secondary Outcome
Title Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose
Hide Description Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.
Time Frame 2 to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 177 378 365 363
Measure Type: Number
Unit of Measure: Participants
20 55 54 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
8.Secondary Outcome
Title Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
Hide Description Pain Freedom and no migraine-associated symptoms at 2 hours postdose.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description:
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Number of Participants Analyzed 176 380 369 365
Measure Type: Number
Unit of Measure: Participants
24 78 78 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0974 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK0974 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).
Time Frame Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy.
Adverse Event Reporting Description

Subjective adverse experiences were recorded by the patient in a paper diary.

Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".

 
Arm/Group Title MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Hide Arm/Group Description MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
All-Cause Mortality
MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/177 (0.00%)   1/381 (0.26%)   0/370 (0.00%)   1/366 (0.27%) 
Injury, poisoning and procedural complications         
Traumatic Brain Injury * 1  0/177 (0.00%)  0/381 (0.00%)  0/370 (0.00%)  1/366 (0.27%) 
Vascular disorders         
Hypertension * 1  0/177 (0.00%)  1/381 (0.26%)  0/370 (0.00%)  0/366 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
MK0974 50 mg MK0974 150 mg MK0974 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/177 (25.42%)   69/381 (18.11%)   94/370 (25.41%)   77/366 (21.04%) 
Ear and labyrinth disorders         
Vertigo * 1  3/177 (1.69%)  2/381 (0.52%)  5/370 (1.35%)  10/366 (2.73%) 
Gastrointestinal disorders         
Abdominal Pain Upper * 1  2/177 (1.13%)  4/381 (1.05%)  12/370 (3.24%)  6/366 (1.64%) 
Dry Mouth * 1  9/177 (5.08%)  17/381 (4.46%)  19/370 (5.14%)  19/366 (5.19%) 
Nausea * 1  14/177 (7.91%)  13/381 (3.41%)  19/370 (5.14%)  20/366 (5.46%) 
Vomiting * 1  6/177 (3.39%)  3/381 (0.79%)  6/370 (1.62%)  10/366 (2.73%) 
General disorders         
Fatigue * 1  9/177 (5.08%)  15/381 (3.94%)  25/370 (6.76%)  14/366 (3.83%) 
Nervous system disorders         
Dizziness * 1  13/177 (7.34%)  9/381 (2.36%)  20/370 (5.41%)  12/366 (3.28%) 
Headache * 1  0/177 (0.00%)  3/381 (0.79%)  3/370 (0.81%)  8/366 (2.19%) 
Paraesthesia * 1  3/177 (1.69%)  5/381 (1.31%)  8/370 (2.16%)  9/366 (2.46%) 
Somnolence * 1  7/177 (3.95%)  14/381 (3.67%)  10/370 (2.70%)  11/366 (3.01%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00432237     History of Changes
Other Study ID Numbers: 0974-016
2006_526
First Submitted: February 5, 2007
First Posted: February 7, 2007
Results First Submitted: July 19, 2010
Results First Posted: December 6, 2010
Last Update Posted: July 3, 2015