Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00483704
First received: May 15, 2007
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.


Condition Intervention Phase
Migraines
Drug: Telcagepant 140 mg
Drug: Talcagepant 280 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) [ Time Frame: 2 hours post-dose for the first migraine attack (up to 6 months) ] [ Designated as safety issue: No ]
    Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 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.

  • Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) [ Time Frame: 2 hours post-dose for the first migraine attack (up to 6 months) ] [ 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.

  • Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose [ Time Frame: 2 hours post-dose (up to 6 months) ] [ Designated as safety issue: No ]
    Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.

  • Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose [ Time Frame: 2 hours post-dose (up to 6 months) ] [ Designated as safety issue: No ]
    Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.

  • Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) [ Time Frame: 2 hours post-dose for the first migraine attack (up to 6 months) ] [ 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 Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) [ Time Frame: 2 hours post-dose for the first migraine attack (up to 6 months) ] [ 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 Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) [ Time Frame: 2 hours post-dose for the first migraine attack (up to 6 months) ] [ Designated as safety issue: No ]
    The participant recorded whether nausea was present or absent at each of the predefined time points.

  • Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) [ Time Frame: Up to 48 hours post-dose for the first migraine attack (up to 6 months) ] [ Designated as safety issue: Yes ]
    AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.

  • Number of Participants Discontinuing Study Medication Due to an AE [ Time Frame: Up to the 4th dose of study medication (up to 6 months) ] [ Designated as safety issue: Yes ]
    Participants discontinuing study medication due to an AE were reported for all migraine attacks.


Secondary Outcome Measures:
  • Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) [ Time Frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) ] [ Designated as safety issue: No ]
    Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. 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.

  • Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) [ Time Frame: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months) ] [ Designated as safety issue: No ]
    Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 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 48 hours after dosing with the study medication.

  • Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) [ Time Frame: 2 hours post-dose for the first migraine attack (up to 6 months) ] [ Designated as safety issue: No ]
    TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.

  • Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) [ Time Frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) ] [ Designated as safety issue: No ]
    TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.


Enrollment: 1935
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telcagepant 140 mg
Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Drug: Telcagepant 140 mg
Telcagepant 140 mg tablets
Experimental: Telcagepant 280 mg
Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
Drug: Talcagepant 280 mg
Telcagepant 280 mg tablets
Placebo Comparator: Control Group 1
Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Drug: Telcagepant 140 mg
Telcagepant 140 mg tablets
Drug: Placebo
Placebo tablets
Placebo Comparator: Control Group 2
Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Drug: Telcagepant 140 mg
Telcagepant 140 mg tablets
Drug: Placebo
Placebo tablets

  Eligibility

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

Inclusion Criteria:

  • History of migraines within the past year
  • 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
  • Use acceptable contraception throughout the study
  • Able to complete the study questionnaire(s) and paper diary
  • Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

  • Pregnant or breast-feeding or is expecting to become pregnant during the study
  • Difficulty distinguishing his/her migraine attacks from tension or interval headaches
  • A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
  • More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
  • Greater than 50 years old at the age of migraine onset
  • Previously taken telcagepant
  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: NCT00483704

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: NCT00483704     History of Changes
Other Study ID Numbers: 0974-031, MK-0974-031, 2007_546
Study First Received: May 15, 2007
Results First Received: July 14, 2014
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
multiple attacks of moderate to severe migraine headaches

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014