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

NCT ID: NCT00483704

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1935 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-14
• Study Completion Date: 2009-03-25

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.

Conditions

Migraines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telcagepant 140 mg

Intervention Type: DRUG

Telcagepant 140 mg tablets

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.

Group Type: EXPERIMENTAL

Talcagepant 280 mg

Intervention Type: DRUG

Telcagepant 280 mg tablets

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.

Group Type: PLACEBO_COMPARATOR

Telcagepant 140 mg

Intervention Type: DRUG

Telcagepant 140 mg tablets

Placebo

Intervention Type: DRUG

Placebo tablets

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.

Group Type: PLACEBO_COMPARATOR

Telcagepant 140 mg

Intervention Type: DRUG

Telcagepant 140 mg tablets

Placebo

Intervention Type: DRUG

Placebo tablets

Interventions

Telcagepant 140 mg

Telcagepant 140 mg tablets

Intervention Type: DRUG

Talcagepant 280 mg

Telcagepant 280 mg tablets

Intervention Type: DRUG

Placebo

Placebo tablets

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8.

Reference Type: DERIVED

PMID: 20974601 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-0974-031

Identifier Type: OTHER

Identifier Source: secondary_id

2007_546

Identifier Type: OTHER

Identifier Source: secondary_id

0974-031

Identifier Type: -

Identifier Source: org_study_id