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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00662818
First received: April 17, 2008
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
Heart Disease
Cerebrovascular Accident
TIA (Transient Ischemic Attack)
Vascular Diseases
Peripheral Vascular Diseases
Drug: Telcagepant
Drug: Acetaminophen/Paracetamol
Drug: Placebo to Telcagepant
Drug: Placebo to Acetaminophen/Paracetamol
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1) [ Time Frame: 2 hours post-dose (Up to 6 weeks) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose [ Time Frame: Within 14 days of any dose of study medication (Up to 16 weeks) ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose [ Time Frame: Up to 48 hours post-dose (Up to 14 weeks) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1) [ Time Frame: 2 hours post-dose (Up to 6 weeks) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose [ Time Frame: Up to 48 hours after the dose of any study medication (Up to 14 weeks) ] [ Designated as safety issue: Yes ]
    Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.

  • Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) [ Time Frame: 2 hours post-dose (Up to 6 weeks) ] [ Designated as safety issue: No ]
    The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.

  • Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) [ Time Frame: 2 Hours post-dose (Up to 6 weeks) ] [ Designated as safety issue: No ]
    The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.

  • Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1) [ Time Frame: 2 hours post-dose (Up to 6 weeks) ] [ Designated as safety issue: No ]
    The participant recorded whether nausea was present or absent at each of the predefined time points.

  • Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose [ Time Frame: Up to 24 hours post-dose (Up to 14 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 165
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Drug: Telcagepant
Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
Drug: Acetaminophen/Paracetamol
Acetaminophen/Paracetamol (500 mg X 2 dosage units)
Drug: Placebo to Telcagepant
Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
Drug: Placebo to Acetaminophen/Paracetamol
Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)
Experimental: Placebo and APAP 1000 mg→Telcagepant 300 mg
Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Drug: Telcagepant
Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
Drug: Acetaminophen/Paracetamol
Acetaminophen/Paracetamol (500 mg X 2 dosage units)
Drug: Placebo to Telcagepant
Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
Drug: Placebo to Acetaminophen/Paracetamol
Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00662818

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

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00662818     History of Changes
Other Study ID Numbers: 0974-034, MK-0974-034, 2007_545
Study First Received: April 17, 2008
Results First Received: September 5, 2014
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Vascular Diseases
Vascular Diseases
Cerebral Infarction
Heart Diseases
Ischemic Attack, Transient
Migraine Disorders
Peripheral Arterial Disease
Stroke
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014