MK3207 for Treatment of Acute Migraines (3207-005)

• ClinicalTrials.gov Identifier: NCT00712725
• Recruitment Status: Completed
• First Posted: July 10, 2008
• Results First Posted: November 22, 2010
• Last Update Posted: February 2, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Migraine	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)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 676 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine
• Study Start Date: July 2008
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; MK3207- 2.5 mg	Drug: MK3207- 2.5 mg; Arm 1: MK3207 2.5 mg taken after migraine onset.; Other Name: MK3207
Experimental: 2; MK3207- 5 mg	Drug: MK3207- 5 mg; Arm 2: MK3207 5 mg taken after migraine onset.; Other Name: MK3207
Experimental: 3; MK3207- 10 mg	Drug: MK3207- 10 mg; Arm 3: MK3207 10 mg taken after migraine onset.; Other Name: MK3207
Experimental: 4; MK3207- 20 mg	Drug: MK3207- 20 mg; Arm 4: MK3207 20 mg taken after migraine onset.; Other Name: MK3207
Experimental: 5; MK3207- 50 mg	Drug: MK3207- 50 mg; Arm 5: MK3207 50 mg taken after migraine onset.; Other Name: MK3207
Experimental: 6; MK3207- 100 mg	Drug: MK3207- 100 mg; Arm 6: MK3207 100 mg taken after migraine onset.; Other Name: MK3207
Placebo Comparator: 7; Placebo	Drug: Comparator: placebo (unspecified); Placebo taken after migraine onset.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Pain Relief (PR) [ Time Frame: 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
2. Absence of Photophobia [ Time Frame: 2 hours postdose ]
   Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
3. Absence of Phonophobia [ Time Frame: 2 hours postdose ]
   Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
4. Absence of Nausea [ Time Frame: 2 hours postdose ]
   Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
5. Sustained Pain Freedom (SPF) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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: 10.1177/0333102411398399. Epub 2011 Mar 7.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00712725
• Other Study ID Numbers: 3207-005; 2008_536
• First Posted: July 10, 2008
• Results First Posted: November 22, 2010
• Last Update Posted: February 2, 2015
• Last Verified: January 2015

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases