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

Phase 3

Completed

• Conditions: Migraines
• Interventions: Drug: Telcagepant 140 mg; Drug: Talcagepant 280 mg; Drug: Placebo

• Registration Number: NCT00483704
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-07
• Study Start: 2008-08-14
• Primary Completion: 2009-03-25
• Study Completion: 2009-03-25
• Results First Submitted: 2014-07-14
• Results First Submitted QC: 2014-08-27
• Results First Posted: 2014-08-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1935

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telcagepant 140 mg	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.
Telcagepant 280 mg	Talcagepant 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.
Control Group 1	Telcagepant 140 mg	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.
Control Group 1	Placebo	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.
Control Group 2	Telcagepant 140 mg	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.
Control Group 2	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)	2 hours post-dose for the first migraine attack (up to 6 months)	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)	2 hours post-dose for the first migraine attack (up to 6 months)	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	2 hours post-dose (up to 6 months)	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	2 hours post-dose (up to 6 months)	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)	2 hours post-dose for the first migraine attack (up to 6 months)	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)	2 hours post-dose for the first migraine attack (up to 6 months)	The participant recorded whether phonophobia (sensitivity to sound) 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)	Up to 48 hours post-dose for the first migraine attack (up to 6 months)	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	Up to the 4th dose of study medication (up to 6 months)	Participants discontinuing study medication due to an AE were reported for all migraine attacks.
Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)	2 hours post-dose for the first migraine attack (up to 6 months)	The participant recorded whether nausea was present or absent at each of the predefined time points.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)	From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)	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)	From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)	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)	2 hours post-dose for the first migraine attack (up to 6 months)	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)	From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)	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.