Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo to telcagepant tablets; Drug: Rizatriptan 10 mg tablets; Drug: Telcagepant 300 mg soft gel capsules; Drug: Telcagepant 280 mg tablets; Drug: Placebo to telcagepant capsules; Drug: Placebo to rizatriptan tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443209

0974-012

MK-0974-012 (Other Identifier)

2006_524 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.

Enrollment: 1,068 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 1 year history of migraine (with or without aura)
• Females of child bearing potential must use acceptable contraception throughout trial
• In general good health based on screening assessment

Exclusion criteria

• Pregnant/breast-feeding (or is a female expecting to conceive during study period)
• 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
• Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
• History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
• 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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1,068 participants in 2 patient groups

Telcagepant 280 mg/300 mg

Experimental group

Description:

Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.

Treatment:

Drug: Telcagepant 280 mg tablets

Drug: Placebo to rizatriptan tablets

Drug: Telcagepant 300 mg soft gel capsules

Rizatriptan 10 mg

Active Comparator group

Description:

Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.

Treatment:

Drug: Placebo to telcagepant capsules

Drug: Rizatriptan 10 mg tablets

Drug: Placebo to telcagepant tablets