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

NCT00442936 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1380

Last updated 2018-10-17

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Telcagepant potassium 150 mg

Telcagepant 150 mg liquid-filled soft gel capsules

DRUG

Telcagepant potassium 300 mg

Telcagepant 300 mg liquid-filled soft gel capsules

DRUG

Zolmitriptan 5 mg

Zolmitriptan 5 mg tablets

DRUG

Placebo to telcagepant 150 mg

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

DRUG

Placebo to tecagepant 300 mg

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

DRUG

Placebo to zolmitriptan 5 mg

Placebo to match zolmitriptan 5 mg tablets

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-15
Primary Completion
2007-10-02
Completion
2007-10-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442936 on ClinicalTrials.gov