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Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)

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ClinicalTrials.gov Identifier: NCT00701389
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : September 8, 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: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: telcagepant potassium
Drug: sumatriptan
Drug: sumatriptan placebo
Drug: telcagepant potassium placebo
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequence 1: A→C→D→B Sequence 2: B→D→C→A Sequence 3: C→B→A→D Sequence 4: D→A→B→C
Hide Arm/Group Description Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout. Participants receive the following: Period 1:single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout. Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout. Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.
Period Title: Period 1
Started 6 6 6 6
Completed 6 6 6 6
Not Completed 0 0 0 0
Period Title: Period 2
Started 6 6 6 6
Completed 6 6 6 6
Not Completed 0 0 0 0
Period Title: Period 3
Started 6 6 6 6
Completed 6 6 6 6
Not Completed 0 0 0 0
Period Title: Period 4
Started 6 6 6 6
Completed 6 6 6 6
Not Completed 0 0 0 0
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description All participants enrolled in the study
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
35.0
(21 to 56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
17
  70.8%
Male
7
  29.2%
1.Primary Outcome
Title Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)
Hide Description In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).
Time Frame Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered sumatriptan with telcagepant or sumatriptan alone in either Periods 1, 2, 3, or 4 regardless of sequence and had evaluable blood pressure data obtained.
Arm/Group Title 100 mg Sumatriptan/600 mg Telcagepant 100 mg Sumatriptan/Telcagepant Placebo
Hide Arm/Group Description:
Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
Overall Number of Participants Analyzed 24 22
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
89.0
(85.1 to 92.8)
87.5
(83.6 to 91.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 mg Sumatriptan/600 mg Telcagepant, 100 mg Sumatriptan/Telcagepant Placebo
Comments 100 mg sumatriptan/600 mg telcagepant minus 100 mg sumatriptan/telcagepant placebo
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper bound of the 90% CI is less than 5 mmHg, the primary hypothesis would be supported.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Effect Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value 1.5
Confidence Interval (2-Sided) 90%
0.0 to 3.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)
Hide Description In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).
Time Frame Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered telcagepant or placebo in either Periods 1, 2, 3, or 4 regardless of sequence.
Arm/Group Title Sumatriptan Placebo/600 mg Telcagepant Sumatriptan Placebo/Telcagepant Placebo
Hide Arm/Group Description:
Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
Overall Number of Participants Analyzed 24 24
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
84.7
(80.8 to 88.6)
83.5
(79.6 to 87.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan Placebo/600 mg Telcagepant, Sumatriptan Placebo/Telcagepant Placebo
Comments sumatriptan placebo/600 mg telcagepant minus sumatriptan placebo/telcagepant placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Effect Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value 1.2
Confidence Interval (2-Sided) 90%
-0.2 to 2.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Experienced an Adverse Event During the Study
Hide Description Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.
Time Frame up to 14 days after last dose of study drug (up to 10 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.
Arm/Group Title 100 mg Sumatriptan/600 mg Telcagepant 100 mg Sumatriptan/Telcagepant Placebo Sumatriptan Placebo/600 mg Telcagepant Sumatriptan Placebo/Telcagepant Placebo
Hide Arm/Group Description:
Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
Overall Number of Participants Analyzed 24 24 24 24
Measure Type: Number
Unit of Measure: Participants
9 12 8 10
4.Secondary Outcome
Title Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event
Hide Description Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The number of participants who were discontinued from the study due to adverse event was summarized.
Time Frame up to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.
Arm/Group Title 100 mg Sumatriptan/600 mg Telcagepant 100 mg Sumatriptan/Telcagepant Placebo Sumatriptan Placebo/600 mg Telcagepant Sumatriptan Placebo/Telcagepant Placebo
Hide Arm/Group Description:
Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
Participants who received single oral dose of generic placebo/600 mg telcagepant in either Period 1, 2, 3, or 4 in the crossover
Participants who received single oral dose of generic placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
Overall Number of Participants Analyzed 24 24 24 24
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
Time Frame up to 14 days after last dose of study drug (up to 10 weeks)
Adverse Event Reporting Description All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.
 
Arm/Group Title 100 mg Sumatriptan/600 mg Telcagepant 100 mg Sumatriptan/Telcagepant Placebo Sumatriptan Placebo/600 mg Telcagepant Sumatriptan Placebo/Telcagepant Placebo
Hide Arm/Group Description Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
All-Cause Mortality
100 mg Sumatriptan/600 mg Telcagepant 100 mg Sumatriptan/Telcagepant Placebo Sumatriptan Placebo/600 mg Telcagepant Sumatriptan Placebo/Telcagepant Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
100 mg Sumatriptan/600 mg Telcagepant 100 mg Sumatriptan/Telcagepant Placebo Sumatriptan Placebo/600 mg Telcagepant Sumatriptan Placebo/Telcagepant Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
100 mg Sumatriptan/600 mg Telcagepant 100 mg Sumatriptan/Telcagepant Placebo Sumatriptan Placebo/600 mg Telcagepant Sumatriptan Placebo/Telcagepant Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/24 (20.83%)   7/24 (29.17%)   5/24 (20.83%)   7/24 (29.17%) 
Gastrointestinal disorders         
Nausea  1  1/24 (4.17%)  2/24 (8.33%)  3/24 (12.50%)  1/24 (4.17%) 
Vomiting  1  0/24 (0.00%)  2/24 (8.33%)  0/24 (0.00%)  1/24 (4.17%) 
Nervous system disorders         
Headache  1  1/24 (4.17%)  2/24 (8.33%)  1/24 (4.17%)  1/24 (4.17%) 
Migraine  1  3/24 (12.50%)  4/24 (16.67%)  1/24 (4.17%)  5/24 (20.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MdeDRA 11.0
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 guidelines.
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: NCT00701389     History of Changes
Other Study ID Numbers: 0974-026
2008_500
First Submitted: June 17, 2008
First Posted: June 19, 2008
Results First Submitted: August 27, 2014
Results First Posted: September 8, 2014
Last Update Posted: October 17, 2018