MK3207 for Treatment of Acute Migraines (3207-005)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: MK3207- 100 mg; Drug: MK3207- 50 mg; Drug: MK3207- 5 mg; Drug: MK3207- 20 mg; Drug: MK3207- 10 mg; Drug: MK3207- 2.5 mg; Drug: Comparator: placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712725

3207-005

2008_536

Details and patient eligibility

About

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

Enrollment: 676 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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676 participants in 7 patient groups, including a placebo group

1

Experimental group

Description:

MK3207- 2.5 mg

Treatment:

Drug: MK3207- 2.5 mg

2

Experimental group

Description:

MK3207- 5 mg

Treatment:

Drug: MK3207- 5 mg

3

Experimental group

Description:

MK3207- 10 mg

Treatment:

Drug: MK3207- 10 mg

4

Experimental group

Description:

MK3207- 20 mg

Treatment:

Drug: MK3207- 20 mg

5

Experimental group

Description:

MK3207- 50 mg

Treatment:

Drug: MK3207- 50 mg

6

Experimental group

Description:

MK3207- 100 mg

Treatment:

Drug: MK3207- 100 mg

7

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo (unspecified)