Clinical Trials/NCT00712725

NCT00712725

Completed

Phase 2

A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine

Merck Sharp & Dohme LLC0 sites676 target enrollmentJuly 2008

ConditionsMigraine

InterventionsMK3207- 5 mg MK3207- 2.5 mg MK3207- 10 mg MK3207- 20 mg MK3207- 50 mg MK3207- 100 mg

DrugsMK3207- 2.5 mg MK3207- 5 mg MK3207- 10 mg MK3207- 20 mg MK3207- 50 mg MK3207- 100 mg Comparator: placebo (unspecified)

Overview

Phase: Phase 2
Intervention: MK3207- 5 mg
Conditions: Migraine
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 676
Primary Endpoint: Pain Freedom (PF)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

January 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and Women from 18 to 65 years of age
•1+ year history of migraine that typically last from 4 to 72 hours if untreated
•Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
•Not pregnant or planning to become pregnant in next 6 months

Exclusion Criteria

•Pregnant or breast-feeding, or planning to become pregnant in next 6 months
•Cannot distinguish migraine attacks from tension type headaches
•Migraines are mild or resolve without medication in less than 2 hours
•More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
•Basilar type or hemiplegic migraine headaches
•More than 50 years old when migraines began
•History of cardiovascular disorder within last 6 months

Arms & Interventions

2

MK3207- 5 mg

Intervention: MK3207- 5 mg

1

MK3207- 2.5 mg

Intervention: MK3207- 2.5 mg

3

MK3207- 10 mg

Intervention: MK3207- 10 mg

4

MK3207- 20 mg

Intervention: MK3207- 20 mg

5

MK3207- 50 mg

Intervention: MK3207- 50 mg

6

MK3207- 100 mg

Intervention: MK3207- 100 mg

Outcomes

Primary Outcomes

Pain Freedom (PF)

Time Frame: 2 hours postdose

Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): * Grade 0: No pain * Grade 1: Mild pain * Grade 2: Moderate pain * Grade 3: Severe pain