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Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

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ClinicalTrials.gov Identifier: NCT00483704
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : August 29, 2014
Last Update Posted : October 18, 2018
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 Migraines
Interventions Drug: Telcagepant 140 mg
Drug: Talcagepant 280 mg
Drug: Placebo
Enrollment 1935
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Period Title: Randomization
Started 644 645 646
Completed 573 549 555
Not Completed 71 96 91
Reason Not Completed
Withdrawal by Subject             19             28             18
Protocol Violation             14             25             22
Lost to Follow-up             14             14             19
Pregnancy             1             0             0
Physician Decision             2             4             0
Progressive disease             0             0             1
Lack of qualifying migraines             21             25             31
Period Title: Treatment
Started 573 549 555
Completed 444 420 399
Not Completed 129 129 156
Reason Not Completed
Lack of qualifying migraines             101             99             116
Adverse Event             3             5             4
Withdrawal by Subject             16             12             21
Protocol Violation             6             3             5
Lost to Follow-up             2             7             5
Lack of Efficacy             1             1             1
Pregnancy             0             1             0
Physician Decision             0             1             4
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo Total
Hide Arm/Group Description Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. Total of all reporting groups
Overall Number of Baseline Participants 644 645 646 1935
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 644 participants 645 participants 646 participants 1935 participants
43.2  (11.7) 42.6  (11.8) 41.9  (11.7) 42.6  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 644 participants 645 participants 646 participants 1935 participants
Female
542
  84.2%
549
  85.1%
540
  83.6%
1631
  84.3%
Male
102
  15.8%
96
  14.9%
106
  16.4%
304
  15.7%
1.Primary Outcome
Title Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
Hide Description Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
Time Frame 2 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 556 534 539
Measure Type: Number
Unit of Measure: Percentage of participants
21.9 25.1 10.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.54
Confidence Interval (2-Sided) 95%
1.80 to 3.58
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.03
Confidence Interval (2-Sided) 95%
2.15 to 4.27
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
2.Primary Outcome
Title Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
Hide Description Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
Time Frame 2 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 556 534 539
Measure Type: Number
Unit of Measure: Percentage of participants
58.6 56.7 33.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.03
Confidence Interval (2-Sided) 95%
2.35 to 3.90
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.80
Confidence Interval (2-Sided) 95%
2.17 to 3.61
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
3.Primary Outcome
Title Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
Hide Description Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.
Time Frame 2 hours post-dose (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 493 468 485
Measure Type: Number
Unit of Measure: Percentage of participants
9.3 14.1 2.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.85
Confidence Interval (2-Sided) 95%
2.05 to 7.23
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.18
Confidence Interval (2-Sided) 95%
3.36 to 11.39
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
4.Primary Outcome
Title Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
Hide Description Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.
Time Frame 2 hours post-dose (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 469 440 452
Measure Type: Number
Unit of Measure: Percentage of participants
41.8 46.8 22.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.62
Confidence Interval (2-Sided) 95%
1.96 to 3.51
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.23
Confidence Interval (2-Sided) 95%
2.41 to 4.34
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
5.Primary Outcome
Title Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
Hide Description The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Time Frame 2 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for photophobia severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 554 534 539
Measure Type: Number
Unit of Measure: Percentage of participants
52.3 52.4 40.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
1.30 to 2.11
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
1.31 to 2.14
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
6.Primary Outcome
Title Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
Hide Description The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Time Frame 2 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose phonophobia measurement prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 555 534 537
Measure Type: Number
Unit of Measure: Percentage of participants
61.4 59.4 48.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
1.36 to 2.22
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
1.26 to 2.06
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
7.Primary Outcome
Title Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
Hide Description The participant recorded whether nausea was present or absent at each of the predefined time points.
Time Frame 2 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for nausea severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 553 534 538
Measure Type: Number
Unit of Measure: Percentage of participants
72.9 71.7 62.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
1.28 to 2.17
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
1.21 to 2.04
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
8.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
Time Frame Up to 48 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The All-Patients-as-Treated (APaT) Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication for the first migraine attack, they were included in that treatment group.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants who received at least one dose of telcagepant 140 mg.
Participants who received at least one dose of telcagepant 280 mg.
Participants who received at least one dose of placebo.
Overall Number of Participants Analyzed 575 538 564
Measure Type: Number
Unit of Measure: Participants
179 167 157
9.Primary Outcome
Title Number of Participants Discontinuing Study Medication Due to an AE
Hide Description Participants discontinuing study medication due to an AE were reported for all migraine attacks.
Time Frame Up to the 4th dose of study medication (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants who received at least one dose of telcagepant 140 mg.
Participants who received at least one dose of telcagepant 280 mg.
Participants who received at least one dose of placebo.
Overall Number of Participants Analyzed 573 543 561
Measure Type: Number
Unit of Measure: Participants
3 5 4
10.Secondary Outcome
Title Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Hide Description Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.
Time Frame From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 553 529 537
Measure Type: Number
Unit of Measure: Percentage of participants
15.6 19.1 6.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.69
Confidence Interval (2-Sided) 95%
1.78 to 4.07
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.45
Confidence Interval (2-Sided) 95%
2.30 to 5.19
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
11.Secondary Outcome
Title Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
Hide Description Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.
Time Frame From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 48 hrs, or a recurrence question.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 552 526 536
Measure Type: Number
Unit of Measure: Percentage of participants
13.4 17.9 6.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.40
Confidence Interval (2-Sided) 95%
1.56 to 3.69
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.37
Confidence Interval (2-Sided) 95%
2.22 to 5.12
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
12.Secondary Outcome
Title Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
Hide Description TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.
Time Frame 2 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 556 534 539
Measure Type: Number
Unit of Measure: Percentage of participants
19.4 22.3 9.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.36
Confidence Interval (2-Sided) 95%
1.65 to 3.38
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.81
Confidence Interval (2-Sided) 95%
1.97 to 4.01
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
13.Secondary Outcome
Title Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Hide Description TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.
Time Frame From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 24 hours.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Overall Number of Participants Analyzed 553 531 537
Measure Type: Number
Unit of Measure: Percentage of participants
13.7 17.1 6.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.32
Confidence Interval (2-Sided) 95%
1.52 to 3.54
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 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 Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.02
Confidence Interval (2-Sided) 95%
2.00 to 4.56
Estimation Comments An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Time Frame Up to 14 days post-dose (up to 6 1/2 months)
Adverse Event Reporting Description The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
 
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description Participants who received at least one dose of telcagepant 140 mg. Participants who received at least one dose of telcagepant 280 mg. Participants who received at least one dose of placebo.
All-Cause Mortality
Telcagepant 140 mg Telcagepant 280 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Telcagepant 140 mg Telcagepant 280 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/573 (1.40%)      8/543 (1.47%)      4/561 (0.71%)    
Cardiac disorders       
Angina pectoris  1  1/573 (0.17%)  1 0/543 (0.00%)  0 0/561 (0.00%)  0
Palpitations  1  0/573 (0.00%)  0 1/543 (0.18%)  1 0/561 (0.00%)  0
Gastrointestinal disorders       
Abdominal hernia  1  1/573 (0.17%)  1 0/543 (0.00%)  0 0/561 (0.00%)  0
Abdominal pain upper  1  1/573 (0.17%)  1 0/543 (0.00%)  0 0/561 (0.00%)  0
Mallory-Weiss syndrome  1  0/573 (0.00%)  0 0/543 (0.00%)  0 1/561 (0.18%)  1
Hepatobiliary disorders       
Cholecystitis  1  0/573 (0.00%)  0 1/543 (0.18%)  1 0/561 (0.00%)  0
Infections and infestations       
Pneumonia  1  1/573 (0.17%)  1 1/543 (0.18%)  1 0/561 (0.00%)  0
Subcutaneous abscess  1  1/573 (0.17%)  1 0/543 (0.00%)  0 0/561 (0.00%)  0
Investigations       
Platelet count increased  1  0/573 (0.00%)  0 0/543 (0.00%)  0 1/561 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer  1  0/573 (0.00%)  0 0/543 (0.00%)  0 1/561 (0.18%)  1
Hodgkin's disease  1  0/573 (0.00%)  0 1/543 (0.18%)  1 0/561 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  1/573 (0.17%)  1 0/543 (0.00%)  0 0/561 (0.00%)  0
Dizziness  1  0/573 (0.00%)  0 1/543 (0.18%)  1 0/561 (0.00%)  0
Dysarthria  1  0/573 (0.00%)  0 0/543 (0.00%)  0 1/561 (0.18%)  1
Hemiplegia  1  0/573 (0.00%)  0 0/543 (0.00%)  0 1/561 (0.18%)  1
Migraine  1  0/573 (0.00%)  0 3/543 (0.55%)  3 0/561 (0.00%)  0
Renal and urinary disorders       
Renal colic  1  0/573 (0.00%)  0 1/543 (0.18%)  1 0/561 (0.00%)  0
Reproductive system and breast disorders       
Dysfunctional uterine bleeding  1  1/573 (0.17%)  1 0/543 (0.00%)  0 0/561 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/573 (0.00%)  0 1/543 (0.18%)  1 0/561 (0.00%)  0
Vascular disorders       
Aneurysm  1  1/573 (0.17%)  1 0/543 (0.00%)  0 0/561 (0.00%)  0
Deep vein thrombosis  1  0/573 (0.00%)  0 1/543 (0.18%)  1 0/561 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telcagepant 140 mg Telcagepant 280 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   166/573 (28.97%)      144/543 (26.52%)      138/561 (24.60%)    
Gastrointestinal disorders       
Dry mouth  1  61/573 (10.65%)  98 42/543 (7.73%)  82 53/561 (9.45%)  105
Nausea  1  44/573 (7.68%)  59 47/543 (8.66%)  65 37/561 (6.60%)  54
General disorders       
Fatigue  1  48/573 (8.38%)  64 34/543 (6.26%)  43 27/561 (4.81%)  44
Nervous system disorders       
Dizziness  1  36/573 (6.28%)  54 40/543 (7.37%)  57 40/561 (7.13%)  59
Somnolence  1  36/573 (6.28%)  54 32/543 (5.89%)  49 15/561 (2.67%)  26
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
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: NCT00483704     History of Changes
Other Study ID Numbers: 0974-031
MK-0974-031 ( Other Identifier: Merck Protocol Number )
2007_546 ( Other Identifier: Telerx ID Number )
First Submitted: May 15, 2007
First Posted: June 7, 2007
Results First Submitted: July 14, 2014
Results First Posted: August 29, 2014
Last Update Posted: October 18, 2018