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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:
ClinicalTrials.gov Identifier:
NCT00662818
First Posted: April 21, 2008
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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
Actual Study Start Date: March 17, 2008
Study Completion Date: September 2, 2009
Primary Completion Date: September 2, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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 ( Other Identifier: Merck Protocol Number )
2007_545 ( Other Identifier: Telerx ID Number )
First Submitted: April 17, 2008
First Posted: April 21, 2008
Results First Submitted: September 5, 2014
Results First Posted: September 17, 2014
Last Update Posted: May 12, 2017
Last Verified: April 2017

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