Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Telcagepant potassium 300 mg; Drug: Rescue medication; Drug: Placebo to zolmitriptan 5 mg; Drug: Telcagepant potassium 150 mg; Drug: Placebo to telcagepant 150 mg; Drug: Zolmitriptan 5 mg; Drug: Placebo to tecagepant 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442936

0974-011

MK-0974-011 (Other Identifier)

2006_525 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time.

The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.

Enrollment: 1,380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has at least 1 year history of migraine (with or without aura)
• Females of child bearing potential must use acceptable contraception throughout trial.

Exclusion criteria

• Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
• Has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
• Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
• Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
• Has a history of cancer within the last 5 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,380 participants in 4 patient groups, including a placebo group

Telcagepant 150 mg

Experimental group

Description:

Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.

Treatment:

Drug: Telcagepant potassium 150 mg

Drug: Placebo to zolmitriptan 5 mg

Drug: Placebo to tecagepant 300 mg

Drug: Rescue medication

Telcagepant 300 mg

Experimental group

Description:

Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.

Treatment:

Drug: Placebo to telcagepant 150 mg

Drug: Placebo to zolmitriptan 5 mg

Drug: Rescue medication

Drug: Telcagepant potassium 300 mg

Zolmitriptan 5 mg

Active Comparator group

Description:

Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.

Treatment:

Drug: Zolmitriptan 5 mg

Drug: Placebo to telcagepant 150 mg

Drug: Placebo to tecagepant 300 mg

Drug: Rescue medication

Placebo

Placebo Comparator group

Description:

Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.

Treatment:

Drug: Placebo to telcagepant 150 mg

Drug: Placebo to zolmitriptan 5 mg

Drug: Placebo to tecagepant 300 mg

Drug: Rescue medication