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

NCT00443209 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1068

Last updated 2018-10-17

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Telcagepant 300 mg soft gel capsules

One capsule taken orally at onset of migraine

DRUG

Telcagepant 280 mg tablets

One tablet taken orally at onset of migraine

DRUG

Rizatriptan 10 mg tablets

One tablet taken orally at onset of migraine

DRUG

Placebo to telcagepant capsules

One capsule taken orally at onset of migraine

DRUG

Placebo to telcagepant tablets

One tablet taken orally at onset of migraine

DRUG

Placebo to rizatriptan tablets

One tablet taken orally at onset of migraine

Sponsors & Collaborators

Principal Investigators

  • Medical Director · 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
2007-02-21
Primary Completion
2009-01-22
Completion
2009-01-22

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Entities

Diseases
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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 NCT00443209 on ClinicalTrials.gov