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Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)

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ClinicalTrials.gov Identifier: NCT01125774
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : October 3, 2014
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Telcagepant
Drug: Placebo
Enrollment 4548
Recruitment Details  
Pre-assignment Details Participants were randomized to telcagepant 140 mg or placebo. Protocol deviation occurred in which 28 participants (called "duplicate participants") were randomized at more than 1 study site (22 unique participants randomized in total 37 times to telcagepant and 12 times to placebo; 6 unique participants randomized in total 12 times to placebo)
Arm/Group Title Telcagepant 140 mg - Excluding Duplicate Participants Placebo - Excluding Duplicate Participants Telcagepant 140 mg - Duplicate Participants Placebo - Duplicate Participants
Hide Arm/Group Description Participants who were randomized at only 1 study site and were randomized to telcagepant. Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. Participants who were randomized at only 1 study site and were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. Participants who were randomized at more than 1 study site and each time were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Period Title: Overall Study
Started 3018 [1] 1502 [1] 22 [2] 6 [2]
Treated 2638 1322 [3] 21 [4] 5
Completed 1893 948 13 [5] 3 [6]
Not Completed 1125 554 9 3
[1]
Randomized
[2]
Unique participants randomized
[3]
1 mistakenly took telcagepant and is included with telcagepant group for adverse event analysis
[4]
Received telcagepant
[5]
Completed study at least once while treated with telcagepant (otherwise counted "Not Completed")
[6]
Completed study at least once
Arm/Group Title Telcagepant 140 mg Placebo Total
Hide Arm/Group Description Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. Total of all reporting groups
Overall Number of Baseline Participants 3040 1508 4548
Hide Baseline Analysis Population Description
All randomized participants, including those randomized at more than 1 site ("duplicate participants"). Participants randomized at more than 1 site resulting in randomization into both telcagepant 140 mg and placebo groups are allocated to the telcagepant 140 mg group.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3040 participants 1508 participants 4548 participants
36.1  (8.6) 35.8  (8.7) 36.0  (8.6)
[1]
Measure Description: Due to missing data, N=3039 and 4547 for Telcagepant 140 mg and Total groups, respectively.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3040 participants 1508 participants 4548 participants
Female
3040
 100.0%
1508
 100.0%
4548
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Clinical Adverse Events (AEs)
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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.
Time Frame Up to 14 days after the last dose of study drug (Up to 6.5 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 2660 1326
Measure Type: Number
Unit of Measure: Participants
1582 804
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 [Not Specified]
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percent incidence
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-4.4 to 2.1
Estimation Comments Telcagepant percent incidence versus Placebo percent incidence
2.Primary Outcome
Title Number of Participants Who Discontinued Study Due to a Clinical 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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 2660 1326
Measure Type: Number
Unit of Measure: Participants
66 36
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 [Not Specified]
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percent incidence
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.4 to 0.8
Estimation Comments Telcagepant percent incidence versus Placebo percent incidence
3.Primary Outcome
Title Number of Participants With Laboratory AEs
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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 2610 1305
Measure Type: Number
Unit of Measure: Participants
76 30
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 [Not Specified]
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percent incidence
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.5 to 1.6
Estimation Comments Telcagepant percent incidence versus Placebo percent incidence
4.Primary Outcome
Title Number of Participants Who Discontinued Study Due to a Laboratory 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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 2610 1305
Measure Type: Number
Unit of Measure: Participants
8 2
5.Primary Outcome
Title Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
Hide Description Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 887 447
Mean (Standard Error)
Unit of Measure: Days per month
8.8  (0.19) 9.3  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant 140 mg, Placebo
Comments This measure tests the primary hypothesis, that telcagepant 140 mg is superior to placebo as measured by mean monthly headache days in participants with MRM or PMM
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments α=0.0499
Method Longitudinal data analysis (LDA)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.1 to 0.1
Estimation Comments Difference is Telcagepant 140 mg versus Placebo
6.Secondary Outcome
Title Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
Hide Description Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 731 382
Mean (Standard Error)
Unit of Measure: Days per month
9.3  (0.20) 9.6  (0.28)
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 0.369
Comments To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499
Method LDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.0 to 0.4
Estimation Comments Difference is Telcagepant 140 mg versus Placebo
7.Secondary Outcome
Title Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
Hide Description Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 887 448
Mean (Standard Error)
Unit of Measure: Days per month
2.5  (0.05) 2.9  (0.08)
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 To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499
Method LDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.5 to -0.2
Estimation Comments Difference is Telcagepant 140 mg versus Placebo
8.Secondary Outcome
Title Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
Hide Description Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 731 383
Mean (Standard Error)
Unit of Measure: Days per month
2.6  (0.06) 3.0  (0.08)
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 To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499
Method LDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.5 to -0.2
Estimation Comments Difference is Telcagepant 140 mg versus Placebo
9.Secondary Outcome
Title Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline
Hide Description Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle.
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the PMM subgroup and reported average of ≥3 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description:
Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Number of Participants Analyzed 344 151
Mean (Standard Error)
Unit of Measure: Days per month
2.1  (0.08) 2.2  (0.12)
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 0.393
Comments To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499
Method LDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Estimation Comments Difference is Telcagepant 140 mg versus Placebo
Time Frame Up to 14 days after the last dose of study drug (Up to 6.5 months)
Adverse Event Reporting Description APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
 
Arm/Group Title Telcagepant 140 mg Placebo
Hide Arm/Group Description Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
All-Cause Mortality
Telcagepant 140 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Telcagepant 140 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/2660 (0.94%)      10/1326 (0.75%)    
Cardiac disorders     
Cardiac arrest  1  1/2660 (0.04%)  2 0/1326 (0.00%)  0
Myocardial infarction  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Gastrointestinal disorders     
Pancreatitis  1  2/2660 (0.08%)  2 0/1326 (0.00%)  0
Peptic ulcer haemorrhage  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
General disorders     
Chest pain  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis obstructive  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Hypersensitivity  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Cervicitis  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Injury, poisoning and procedural complications     
Comminuted fracture  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
Contusion  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Post procedural haemorrhage  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Traumatic brain injury  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
Investigations     
Alanine aminotransferase increased  1  3/2660 (0.11%)  3 0/1326 (0.00%)  0
Aspartate aminotransferase increased  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Metabolism and nutrition disorders     
Hypocalcaemia  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Hypokalaemia  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Hyponatraemia  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Metabolic acidosis  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Breast cancer  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Breast cancer metastatic  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Nervous system disorders     
Cervicobrachial syndrome  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Hypoxic-ischaemic encephalopathy  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Migraine with aura  1  1/2660 (0.04%)  1 1/1326 (0.08%)  1
Post-traumatic headache  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
VIIth nerve paralysis  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Ectopic pregnancy  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
Umbilical cord prolapse  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
Psychiatric disorders     
Acute stress disorder  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
Anxiety  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Depression  1  2/2660 (0.08%)  2 0/1326 (0.00%)  0
Mental status changes  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Suicidal ideation  1  1/2660 (0.04%)  1 1/1326 (0.08%)  1
Renal and urinary disorders     
Calculus urinary  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Nephrolithiasis  1  0/2660 (0.00%)  0 1/1326 (0.08%)  1
Renal failure  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Reproductive system and breast disorders     
Endometriosis  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Dyspnoea  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Non-cardiogenic pulmonary oedema  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Respiratory acidosis  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Respiratory failure  1  1/2660 (0.04%)  1 0/1326 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   819/2660 (30.79%)      413/1326 (31.15%)    
Gastrointestinal disorders     
Diarrhoea  1  186/2660 (6.99%)  292 90/1326 (6.79%)  128
Dry mouth  1  174/2660 (6.54%)  359 85/1326 (6.41%)  168
Nausea  1  270/2660 (10.15%)  467 165/1326 (12.44%)  264
General disorders     
Fatigue  1  135/2660 (5.08%)  194 65/1326 (4.90%)  130
Infections and infestations     
Nasopharyngitis  1  190/2660 (7.14%)  226 102/1326 (7.69%)  122
Nervous system disorders     
Dizziness  1  204/2660 (7.67%)  340 100/1326 (7.54%)  166
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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. Sponsor review can be expedited to meet publication timelines.
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: NCT01125774     History of Changes
Other Study ID Numbers: 0974-065
2010_535 ( Other Identifier: Merck Registration Number )
First Submitted: May 17, 2010
First Posted: May 18, 2010
Results First Submitted: October 1, 2014
Results First Posted: October 3, 2014
Last Update Posted: October 23, 2018