Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

Cerebrovascular Accident Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662818
• Other study ID #: 0974-034
• Secondary ID: MK-0974-0342007_
• Status: Completed
• Phase: Phase 3
• Start date: March 17, 2008
• Est. completion date: September 2, 2009

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 2, 2009
• Est. primary completion date: September 2, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stable coronary artery disease for 3 months or more

• 18 years of age or older with a history of migraine with or without aura

• Must use acceptable contraception throughout the study

Exclusion Criteria:

• Pregnant, breast-feeding, or planning to become pregnant during this study

• 50 years of age or older when migraines began

• Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)

• History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Heart Disease
• Heart Diseases
• Ischemic Attack, Transient
• Migraine Disorders
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stroke
• TIA (Transient Ischemic Attack)
• Vascular Diseases

Intervention

Drug:
• Telcagepant
Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
• Acetaminophen/Paracetamol
Acetaminophen/Paracetamol (500 mg X 2 dosage units)
• Placebo to Telcagepant
Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
• Placebo to Acetaminophen/Paracetamol
Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)	Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.	2 hours post-dose (Up to 6 weeks)
Primary	Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Within 14 days of any dose of study medication (Up to 16 weeks)
Primary	Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to 48 hours post-dose (Up to 14 weeks)
Secondary	Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)	Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.	2 hours post-dose (Up to 6 weeks)
Secondary	Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose	Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.	Up to 48 hours after the dose of any study medication (Up to 14 weeks)
Secondary	Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)	The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.	2 hours post-dose (Up to 6 weeks)
Secondary	Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)	The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.	2 Hours post-dose (Up to 6 weeks)
Secondary	Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)	The participant recorded whether nausea was present or absent at each of the predefined time points.	2 hours post-dose (Up to 6 weeks)
Secondary	Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose	SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.	Up to 24 hours post-dose (Up to 14 weeks)