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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1068 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-21

Study Completion Date

2009-01-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Telcagepant 280 mg/300 mg

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.

Group Type EXPERIMENTAL

Telcagepant 300 mg soft gel capsules

Intervention Type DRUG

One capsule taken orally at onset of migraine

Telcagepant 280 mg tablets

Intervention Type DRUG

One tablet taken orally at onset of migraine

Placebo to rizatriptan tablets

Intervention Type DRUG

One tablet taken orally at onset of migraine

Rizatriptan 10 mg

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.

Group Type ACTIVE_COMPARATOR

Rizatriptan 10 mg tablets

Intervention Type DRUG

One tablet taken orally at onset of migraine

Placebo to telcagepant capsules

Intervention Type DRUG

One capsule taken orally at onset of migraine

Placebo to telcagepant tablets

Intervention Type DRUG

One tablet taken orally at onset of migraine

Interventions

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Telcagepant 300 mg soft gel capsules

One capsule taken orally at onset of migraine

Intervention Type DRUG

Telcagepant 280 mg tablets

One tablet taken orally at onset of migraine

Intervention Type DRUG

Rizatriptan 10 mg tablets

One tablet taken orally at onset of migraine

Intervention Type DRUG

Placebo to telcagepant capsules

One capsule taken orally at onset of migraine

Intervention Type DRUG

Placebo to telcagepant tablets

One tablet taken orally at onset of migraine

Intervention Type DRUG

Placebo to rizatriptan tablets

One tablet taken orally at onset of migraine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No