Trial Outcomes & Findings for 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) (NCT NCT00701389)

Last Updated: 2018-10-17

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)

Results posted on

2018-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence 1: A→C→D→B 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.	Sequence 2: B→D→C→A 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.	Sequence 3: C→B→A→D 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.	Sequence 4: D→A→B→C 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 1 STARTED	6	6	6	6
Period 1 COMPLETED	6	6	6	6
Period 1 NOT COMPLETED	0	0	0	0
Period 2 STARTED	6	6	6	6
Period 2 COMPLETED	6	6	6	6
Period 2 NOT COMPLETED	0	0	0	0
Period 3 STARTED	6	6	6	6
Period 3 COMPLETED	6	6	6	6
Period 3 NOT COMPLETED	0	0	0	0
Period 4 STARTED	6	6	6	6
Period 4 COMPLETED	6	6	6	6
Period 4 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Participants n=24 Participants All participants enrolled in the study
Age, Continuous	35.0 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	100 mg Sumatriptan/600 mg Telcagepant n=24 Participants Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	100 mg Sumatriptan/Telcagepant Placebo n=22 Participants Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover	Sumatriptan Placebo/600 mg Telcagepant Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	Sumatriptan Placebo/Telcagepant Placebo Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)	89.0 mmHg Interval 85.1 to 92.8	87.5 mmHg Interval 83.6 to 91.4	—	—

SECONDARY outcome

Timeframe: Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)

Population: Participants who were administered telcagepant or placebo in either Periods 1, 2, 3, or 4 regardless of sequence.

Outcome measures

Outcome measures
Measure	100 mg Sumatriptan/600 mg Telcagepant n=24 Participants Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	100 mg Sumatriptan/Telcagepant Placebo n=24 Participants Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover	Sumatriptan Placebo/600 mg Telcagepant Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	Sumatriptan Placebo/Telcagepant Placebo Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)	84.7 mmHg Interval 80.8 to 88.6	83.5 mmHg Interval 79.6 to 87.3	—	—

SECONDARY outcome

Timeframe: up to 14 days after last dose of study drug (up to 10 weeks)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	100 mg Sumatriptan/600 mg Telcagepant n=24 Participants Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	100 mg Sumatriptan/Telcagepant Placebo n=24 Participants Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover	Sumatriptan Placebo/600 mg Telcagepant n=24 Participants Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	Sumatriptan Placebo/Telcagepant Placebo n=24 Participants Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
Number of Participants Who Experienced an Adverse Event During the Study	9 Participants	12 Participants	8 Participants	10 Participants

SECONDARY outcome

Timeframe: up to 10 weeks

Outcome measures

Outcome measures
Measure	100 mg Sumatriptan/600 mg Telcagepant n=24 Participants Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	100 mg Sumatriptan/Telcagepant Placebo n=24 Participants Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover	Sumatriptan Placebo/600 mg Telcagepant n=24 Participants Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	Sumatriptan Placebo/Telcagepant Placebo n=24 Participants Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

100 mg Sumatriptan/600 mg Telcagepant

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

100 mg Sumatriptan/Telcagepant Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Sumatriptan Placebo/600 mg Telcagepant

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sumatriptan Placebo/Telcagepant Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	100 mg Sumatriptan/600 mg Telcagepant n=24 participants at risk Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	100 mg Sumatriptan/Telcagepant Placebo n=24 participants at risk Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover	Sumatriptan Placebo/600 mg Telcagepant n=24 participants at risk Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover	Sumatriptan Placebo/Telcagepant Placebo n=24 participants at risk Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
Gastrointestinal disorders Nausea	4.2% 1/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	8.3% 2/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	12.5% 3/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	4.2% 1/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.
Gastrointestinal disorders Vomiting	0.00% 0/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	8.3% 2/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	0.00% 0/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	4.2% 1/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.
Nervous system disorders Headache	4.2% 1/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	8.3% 2/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	4.2% 1/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	4.2% 1/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.
Nervous system disorders Migraine	12.5% 3/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	16.7% 4/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	4.2% 1/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.	20.8% 5/24 • up to 14 days after last dose of study drug (up to 10 weeks) 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.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER