MK3207 for Treatment of Acute Migraines (3207-005)

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: MK3207- 20 mg; Drug: MK3207- 50 mg; Drug: MK3207- 100 mg; Drug: MK3207- 10 mg; Drug: MK3207- 5 mg; Drug: MK3207- 2.5 mg

• Registration Number: NCT00712725
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-10-22
• Results First Submitted QC: 2010-10-22
• Results First Posted: 2010-11-22
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	MK3207- 20 mg	MK3207- 20 mg
5	MK3207- 50 mg	MK3207- 50 mg
6	MK3207- 100 mg	MK3207- 100 mg
3	MK3207- 10 mg	MK3207- 10 mg
2	MK3207- 5 mg	MK3207- 5 mg
1	MK3207- 2.5 mg	MK3207- 2.5 mg

Primary Outcome Measures

Name	Time	Method
Pain Freedom (PF)	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

Secondary Outcome Measures

Name	Time	Method
Pain Relief (PR)	2 hours postdose	Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 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
Absence of Photophobia	2 hours postdose	Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
Absence of Phonophobia	2 hours postdose	Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
Absence of Nausea	2 hours postdose	Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
Sustained Pain Freedom (SPF)	2-24 hours postdose	Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.