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

April 17, 2008
September 15, 2014
March 2008
September 2009   (final data collection date for primary outcome measure)
  • 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.
To evaluate the efficacy of MK0974 compared to placebo in the treatment of acute migraine in patients with stable vascular disease, as measured by pain freedom at 2 hours post dose. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00662818 on ClinicalTrials.gov Archive Site
  • 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.
To evaluate the safety and tolerability of MK0974 compared to acetaminophen/paracetamol in the treatment of acute migraine in patients with stable vascular disease following 12 weeks of treatment. [ Time Frame: following 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Migraine Disorders
  • Heart Disease
  • Cerebrovascular Accident
  • TIA (Transient Ischemic Attack)
  • Vascular Diseases
  • Peripheral Vascular Diseases
  • 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: 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.
    Interventions:
    • Drug: Telcagepant
    • Drug: Acetaminophen/Paracetamol
    • Drug: Placebo to Telcagepant
    • Drug: Placebo to Acetaminophen/Paracetamol
  • 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.
    Interventions:
    • Drug: Telcagepant
    • Drug: Acetaminophen/Paracetamol
    • Drug: Placebo to Telcagepant
    • Drug: Placebo to Acetaminophen/Paracetamol
Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6. PubMed PMID: 22221076.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00662818
0974-034, MK-0974-034, 2007_545
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP