- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00701389
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)
September 18, 2018 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Single oral dose of 2 x 300 mg capsules.
single oral dose of 100 mg sumatriptan
single oral dose
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.
|
Single oral dose of 2 x 300 mg capsules.
single oral dose of 100 mg sumatriptan
single oral dose
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.
|
Single oral dose of 2 x 300 mg capsules.
single oral dose of 100 mg sumatriptan
single oral dose
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.
|
Single oral dose of 2 x 300 mg capsules.
single oral dose of 100 mg sumatriptan
single oral dose
single oral dose of 2 MK-0974 placebo capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)
Time Frame: Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)
|
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)
|
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)
|
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)
|
Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event
Time Frame: up to 10 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2007
Primary Completion (Actual)
April 10, 2008
Study Completion (Actual)
April 10, 2008
Study Registration Dates
First Submitted
June 17, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 19, 2008
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
September 18, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Vasoconstrictor Agents
- Sumatriptan
Other Study ID Numbers
- 0974-026
- 2008_500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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