CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,380 enrolled
Drug / intervention
Telcagepant potassium 150 mg +6 moredrug
Likely dose
Telcagepant potassium 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00442936
NCT00442936Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura

Merck Sharp & Dohme LLC·interventional·Posted Mar 5, 2007·Updated Oct 17, 2018

In Brief

A Phase 3 clinical trial evaluating Telcagepant potassium 150 mg, Telcagepant potassium 300 mg, and 5 other interventions for Migraine. Completed, enrolled 1,380 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 5, 2007
Enrollment StartFeb 15, 2007
Primary CompletionOct 2, 2007
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 19.3 years ago

Interventions

Telcagepant potassium 150 mgdrug

Telcagepant 150 mg liquid-filled soft gel capsules

Telcagepant potassium 300 mgdrug

Telcagepant 300 mg liquid-filled soft gel capsules

Zolmitriptan 5 mgdrug

Zolmitriptan 5 mg tablets

Placebo to telcagepant 150 mgdrug

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

Placebo to tecagepant 300 mgdrug

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

Placebo to zolmitriptan 5 mgdrug

Placebo to match zolmitriptan 5 mg tablets

Rescue medicationdrug

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.