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)

Migraine Disorders Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Single Dose Crossover Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK0974 in Migraine Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701389
• Other study ID #: 0974-026
• Secondary ID: 2008_500
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2007
• Est. completion date: April 10, 2008

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours following dosing is less than 5 mmHg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 10, 2008
• Est. primary completion date: April 10, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• History of migraine for longer than 6 months.

• Free from migraine 24 hours before each dosing.

• Judged to be in good health.

• Nonsmoker

Exclusion Criteria:

• Under age of legal consent.

• Legally or mentally incapacitated or has significant emotional problems.

• Taking any medications from about 2 weeks before the first dose of study medication.

• Has had surgery or donated blood or participated in another investigation study within 4 weeks prior to screening

• Currently a regular user of any illicit drugs or has a history of drug/alcohol abuse within about 2 years

• Consumes more than 6 caffeinated beverages per day

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• telcagepant potassium
Single oral dose of 2 x 300 mg capsules.
• sumatriptan
single oral dose of 100 mg sumatriptan
• sumatriptan placebo
single oral dose
• telcagepant potassium placebo
single oral dose of 2 MK-0974 placebo capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Depré M, Macleod C, Palcza J, Behm M, de Lepeleire I, Han T, Panebianco D, Smith W, Blanchard R, Chodakewitz J, Murphy M, de Hoon J. Lack of hemodynamic interaction between CGRP-receptor antagonist telcagepant (MK-0974) and sumatriptan: results from a ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)	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).	Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)
Secondary	Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)	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).	Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)
Secondary	Number of Participants Who Experienced an Adverse Event During the Study	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.	up to 14 days after last dose of study drug (up to 10 weeks)
Secondary	Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event	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.	up to 10 weeks