Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 181 for:    Migraine AND migraine with or without aura

Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

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: NCT00442936
Recruitment Status : Completed
First Posted : March 5, 2007
Results First Posted : August 4, 2014
Last Update Posted : October 17, 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 Migraine
Interventions Drug: Telcagepant potassium 150 mg
Drug: Telcagepant potassium 300 mg
Drug: Zolmitriptan 5 mg
Drug: Placebo to telcagepant 150 mg
Drug: Placebo to tecagepant 300 mg
Drug: Placebo to zolmitriptan 5 mg
Drug: Rescue medication
Enrollment 1380
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Period Title: Overall Study
Started 333 354 345 348
Completed 332 354 344 347
Not Completed 1 0 1 1
Reason Not Completed
Protocol Violation             1             0             1             1
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo Total
Hide Arm/Group Description Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. Total of all reporting groups
Overall Number of Baseline Participants 333 354 345 348 1380
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 333 participants 354 participants 345 participants 348 participants 1380 participants
42.7  (11.2) 42.6  (11.4) 41.7  (11.7) 42.3  (11.6) 42.3  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants 354 participants 345 participants 348 participants 1380 participants
Female
277
  83.2%
300
  84.7%
298
  86.4%
294
  84.5%
1169
  84.7%
Male
56
  16.8%
54
  15.3%
47
  13.6%
54
  15.5%
211
  15.3%
1.Primary Outcome
Title Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose
Hide Description Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 317 338 328 328
Measure Type: Number
Unit of Measure: Participants
56 89 101 29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.26
Confidence Interval (2-Sided) 95%
1.40 to 3.66
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.81
Confidence Interval (2-Sided) 95%
2.42 to 6.00
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
2.Primary Outcome
Title Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose
Hide Description Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 317 338 328 328
Measure Type: Number
Unit of Measure: Participants
157 183 185 88
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.82
Confidence Interval (2-Sided) 95%
2.02 to 3.95
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.44
Confidence Interval (2-Sided) 95%
2.47 to 4.79
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
3.Primary Outcome
Title Number of Participants With Absence of Photophobia at 2 Hours Post-Dose
Hide Description Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 317 338 328 327
Measure Type: Number
Unit of Measure: Participants
143 169 163 92
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.14
Confidence Interval (2-Sided) 95%
1.54 to 2.97
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.61
Confidence Interval (2-Sided) 95%
1.89 to 3.61
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
4.Primary Outcome
Title Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose
Hide Description Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 317 338 326 327
Measure Type: Number
Unit of Measure: Participants
170 193 180 120
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.05
Confidence Interval (2-Sided) 95%
1.49 to 2.82
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.37
Confidence Interval (2-Sided) 95%
1.73 to 3.25
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
5.Primary Outcome
Title Number of Participants With Absence of Nausea at 2 Hours Post-Dose
Hide Description Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline nausea assessment, and had at least one nausea assessment within 2 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 316 337 327 327
Measure Type: Number
Unit of Measure: Participants
212 218 232 179
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.73
Confidence Interval (2-Sided) 95%
1.25 to 2.39
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.13 to 2.13
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
6.Primary Outcome
Title Number of Participants Who Experience At Least One Adverse Event (AE)
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.
Time Frame Up to 14 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 334 352 345 349
Measure Type: Number
Unit of Measure: Participants
105 131 175 112
7.Primary Outcome
Title Number of Participants Who Discontinue Study Drug Due to an AE
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.
Time Frame Up to 48 hours after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The populaton consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 334 352 345 349
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
8.Secondary Outcome
Title Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose
Hide Description SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.
Time Frame 2 to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one pain score measurement at between 2 and 24 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 314 336 328 328
Measure Type: Number
Unit of Measure: Participants
34 66 59 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.80
Confidence Interval (2-Sided) 95%
1.47 to 5.35
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.75
Confidence Interval (2-Sided) 95%
3.15 to 10.51
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
9.Secondary Outcome
Title Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose
Hide Description TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 317 338 328 328
Measure Type: Number
Unit of Measure: Participants
43 76 87 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
1.07 to 2.97
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.34
Confidence Interval (2-Sided) 95%
2.08 to 5.35
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
10.Secondary Outcome
Title Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose
Hide Description TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.
Time Frame 2 to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 to 24 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 to 24 hours post-dose.
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description:
Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Number of Participants Analyzed 315 336 328 328
Measure Type: Number
Unit of Measure: Participants
26 57 51 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.25
Confidence Interval (2-Sided) 95%
1.13 to 4.47
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. 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 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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.21
Confidence Interval (2-Sided) 95%
2.78 to 9.76
Estimation Comments From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.
Time Frame Up to 14 days after last dose of study drug
Adverse Event Reporting Description The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
 
Arm/Group Title Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Hide Arm/Group Description Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
All-Cause Mortality
Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/334 (0.00%)   0/352 (0.00%)   0/345 (0.00%)   1/349 (0.29%) 
Musculoskeletal and connective tissue disorders         
Sensation of heaviness  1  0/334 (0.00%)  0/352 (0.00%)  0/345 (0.00%)  1/349 (0.29%) 
Indicates events were collected by 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 5%
Telcagepant 150 mg Telcagepant 300 mg Zolmitriptan 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/334 (19.76%)   74/352 (21.02%)   107/345 (31.01%)   54/349 (15.47%) 
Gastrointestinal disorders         
Dry mouth  1  18/334 (5.39%)  21/352 (5.97%)  28/345 (8.12%)  13/349 (3.72%) 
Nausea  1  13/334 (3.89%)  17/352 (4.83%)  20/345 (5.80%)  13/349 (3.72%) 
General disorders         
Fatigue  1  14/334 (4.19%)  15/352 (4.26%)  24/345 (6.96%)  8/349 (2.29%) 
Nervous system disorders         
Dizziness  1  15/334 (4.49%)  19/352 (5.40%)  38/345 (11.01%)  20/349 (5.73%) 
Paraesthesia  1  4/334 (1.20%)  6/352 (1.70%)  18/345 (5.22%)  5/349 (1.43%) 
Somnolence  1  15/334 (4.49%)  19/352 (5.40%)  20/345 (5.80%)  14/349 (4.01%) 
Indicates events were collected by 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.
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.
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: NCT00442936     History of Changes
Other Study ID Numbers: 0974-011
MK-0974-011 ( Other Identifier: Merck Protocol Number )
2006_525 ( Other Identifier: Telerx ID Number )
First Submitted: February 28, 2007
First Posted: March 5, 2007
Results First Submitted: June 17, 2014
Results First Posted: August 4, 2014
Last Update Posted: October 17, 2018