MK3207 for Treatment of Acute Migraines (3207-005)

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712725
• Other study ID #: 3207-005
• Secondary ID: 2008_536
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2008
• Last updated: January 23, 2015
• Start date: July 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• MK3207- 2.5 mg
Arm 1: MK3207 2.5 mg taken after migraine onset.
• MK3207- 5 mg
Arm 2: MK3207 5 mg taken after migraine onset.
• MK3207- 10 mg
Arm 3: MK3207 10 mg taken after migraine onset.
• MK3207- 20 mg
Arm 4: MK3207 20 mg taken after migraine onset.
• MK3207- 50 mg
Arm 5: MK3207 50 mg taken after migraine onset.
• MK3207- 100 mg
Arm 6: MK3207 100 mg taken after migraine onset.
• Comparator: placebo (unspecified)
Placebo taken after migraine onset.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Absence of Photophobia	Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.	2 hours postdose	Yes
Secondary	Absence of Phonophobia	Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.	2 hours postdose	Yes
Secondary	Absence of Nausea	Absence of nausea at 2 hours postdose as recorded by patient on paper diary.	2 hours postdose	Yes
Secondary	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	Yes