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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-15

Study Completion Date

2007-10-02

Brief Summary

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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.

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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 150 mg

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.

Group Type EXPERIMENTAL

Telcagepant potassium 150 mg

Intervention Type DRUG

Telcagepant 150 mg liquid-filled soft gel capsules

Placebo to tecagepant 300 mg

Intervention Type DRUG

Placebo to match tecagepant 300 mg liquid-filled soft gel capsules

Placebo to zolmitriptan 5 mg

Intervention Type DRUG

Placebo to match zolmitriptan 5 mg tablets

Rescue medication

Intervention Type DRUG

If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.

Telcagepant 300 mg

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.

Group Type EXPERIMENTAL

Telcagepant potassium 300 mg

Intervention Type DRUG

Telcagepant 300 mg liquid-filled soft gel capsules

Placebo to telcagepant 150 mg

Intervention Type DRUG

Placebo to match telcagepant 150 mg liquid-filled soft gel capsules

Placebo to zolmitriptan 5 mg

Intervention Type DRUG

Placebo to match zolmitriptan 5 mg tablets

Rescue medication

Intervention Type DRUG

If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.

Zolmitriptan 5 mg

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.

Group Type ACTIVE_COMPARATOR

Zolmitriptan 5 mg

Intervention Type DRUG

Zolmitriptan 5 mg tablets

Placebo to telcagepant 150 mg

Intervention Type DRUG

Placebo to match telcagepant 150 mg liquid-filled soft gel capsules

Placebo to tecagepant 300 mg

Intervention Type DRUG

Placebo to match tecagepant 300 mg liquid-filled soft gel capsules

Rescue medication

Intervention Type DRUG

If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo to telcagepant 150 mg

Intervention Type DRUG

Placebo to match telcagepant 150 mg liquid-filled soft gel capsules

Placebo to tecagepant 300 mg

Intervention Type DRUG

Placebo to match tecagepant 300 mg liquid-filled soft gel capsules

Placebo to zolmitriptan 5 mg

Intervention Type DRUG

Placebo to match zolmitriptan 5 mg tablets

Rescue medication

Intervention Type DRUG

If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.

Interventions

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Telcagepant potassium 150 mg

Telcagepant 150 mg liquid-filled soft gel capsules

Intervention Type DRUG

Telcagepant potassium 300 mg

Telcagepant 300 mg liquid-filled soft gel capsules

Intervention Type DRUG

Zolmitriptan 5 mg

Zolmitriptan 5 mg tablets

Intervention Type DRUG

Placebo to telcagepant 150 mg

Placebo to match telcagepant 150 mg liquid-filled soft gel capsules

Intervention Type DRUG

Placebo to tecagepant 300 mg

Placebo to match tecagepant 300 mg liquid-filled soft gel capsules

Intervention Type DRUG

Placebo to zolmitriptan 5 mg

Placebo to match zolmitriptan 5 mg tablets

Intervention Type DRUG

Rescue medication

If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No