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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Migraines

Treatments: Drug: Talcagepant 280 mg; Drug: Telcagepant 140 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483704

MK-0974-031 (Other Identifier)

2007_546 (Other Identifier)

0974-031

Details and patient eligibility

About

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.

Enrollment: 1,935 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,935 participants in 4 patient groups, including a placebo group

Telcagepant 140 mg

Experimental group

Description:

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.

Treatment:

Drug: Telcagepant 140 mg

Telcagepant 280 mg

Experimental group

Description:

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.

Treatment:

Drug: Talcagepant 280 mg

Control Group 1

Placebo Comparator group

Description:

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.

Treatment:

Drug: Telcagepant 140 mg

Drug: Placebo

Control Group 2

Placebo Comparator group

Description:

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.

Treatment:

Drug: Telcagepant 140 mg

Drug: Placebo