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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00701389
First received: June 17, 2008
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
Drug: telcagepant potassium
Drug: sumatriptan
Drug: sumatriptan placebo
Drug: telcagepant potassium placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone) [ Time Frame: Predose up to 150 minutes postdose of each treatment period (up to 10 weeks) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo) [ Time Frame: Predose up to 150 minutes postdose of each treatment period (up to 10 weeks) ] [ Designated as safety issue: No ]
    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).

  • Number of Participants Who Experienced an Adverse Event During the Study [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event [ Time Frame: up to 10 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 24
Study Start Date: December 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: telcagepant potassium
Single oral dose of 2 x 300 mg capsules.
Drug: sumatriptan
single oral dose of 100 mg sumatriptan
Drug: sumatriptan placebo
single oral dose
Drug: telcagepant potassium placebo
single oral dose of 2 MK-0974 placebo capsules
Experimental: 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.
Drug: telcagepant potassium
Single oral dose of 2 x 300 mg capsules.
Drug: sumatriptan
single oral dose of 100 mg sumatriptan
Drug: sumatriptan placebo
single oral dose
Drug: telcagepant potassium placebo
single oral dose of 2 MK-0974 placebo capsules
Experimental: 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.
Drug: telcagepant potassium
Single oral dose of 2 x 300 mg capsules.
Drug: sumatriptan
single oral dose of 100 mg sumatriptan
Drug: sumatriptan placebo
single oral dose
Drug: telcagepant potassium placebo
single oral dose of 2 MK-0974 placebo capsules
Experimental: 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.
Drug: telcagepant potassium
Single oral dose of 2 x 300 mg capsules.
Drug: sumatriptan
single oral dose of 100 mg sumatriptan
Drug: sumatriptan placebo
single oral dose
Drug: telcagepant potassium placebo
single oral dose of 2 MK-0974 placebo capsules

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701389

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00701389     History of Changes
Other Study ID Numbers: 0974-026, 2008_500
Study First Received: June 17, 2008
Results First Received: August 27, 2014
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Sumatriptan
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014