MK3207 for Treatment of Acute Migraines (3207-005)

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

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

Conditions
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Migraine

Intervention / Treatment
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* Drug: MK3207- 2.5 mg
* Drug: MK3207- 5 mg
* Drug: MK3207- 10 mg
* Drug: MK3207- 20 mg
* Drug: MK3207- 50 mg
* Drug: MK3207- 100 mg
* Drug: Comparator: placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK3207- 2.5 mg | Drug: MK3207- 2.5 mg<br>* Arm 1: MK3207 2.5 mg taken after migraine onset.<br>* Other names: MK3207;|
| Experimental: 2<br>MK3207- 5 mg | Drug: MK3207- 5 mg<br>* Arm 2: MK3207 5 mg taken after migraine onset.<br>* Other names: MK3207;|
| Experimental: 3<br>MK3207- 10 mg | Drug: MK3207- 10 mg<br>* Arm 3: MK3207 10 mg taken after migraine onset.<br>* Other names: MK3207;|
| Experimental: 4<br>MK3207- 20 mg | Drug: MK3207- 20 mg<br>* Arm 4: MK3207 20 mg taken after migraine onset.<br>* Other names: MK3207;|
| Experimental: 5<br>MK3207- 50 mg | Drug: MK3207- 50 mg<br>* Arm 5: MK3207 50 mg taken after migraine onset.<br>* Other names: MK3207;|
| Experimental: 6<br>MK3207- 100 mg | Drug: MK3207- 100 mg<br>* Arm 6: MK3207 100 mg taken after migraine onset.<br>* Other names: MK3207;|
| Placebo Comparator: 7<br>Placebo | Drug: Comparator: placebo (unspecified)<br>* Placebo taken after migraine onset.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Freedom (PF) | 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 | 2 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief (PR) | 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 | 2 hours postdose | 
| Absence of Photophobia | Absence of photophobia at 2 hours postdose as recorded by patient on paper diary. | 2 hours postdose | 
| Absence of Phonophobia | Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary. | 2 hours postdose | 
| Absence of Nausea | Absence of nausea at 2 hours postdose as recorded by patient on paper diary. | 2 hours postdose | 
| Sustained Pain Freedom (SPF) | 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. | 2-24 hours postdose |