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

Merck Sharp & Dohme LLC1,935 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,935

Conditions

Migraines

Interventions

Telcagepant 140 mgDRUG

Telcagepant 140 mg tablets

Talcagepant 280 mgDRUG

Telcagepant 280 mg tablets

PlaceboDRUG

Placebo tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)

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.

Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)

Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)

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.

Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)

Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose

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.

Time frame: 2 hours post-dose (up to 6 months)

Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose

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.

Time frame: 2 hours post-dose (up to 6 months)

Data from ClinicalTrials.gov

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Secondary Outcomes

Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)

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.

Time frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)

Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)

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.

Time frame: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)

Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)

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.

Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)

Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)

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.

Time frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)