MK3207 for Treatment of Acute Migraines - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00712725

Purpose

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

Condition	Intervention	Phase
Migraine	Drug: MK3207 Drug: Comparator: placebo (unspecified)	Phase II

MedlinePlus related topics: Migraine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of MK3207 in the Treatment of Acute Migraine

Further study details as provided by Merck:

Primary Outcome Measures:

Effectiveness of MK3207 in the treatment of acute migraine as measured by pain freedom at 2 hours post dose. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of various doses of MK3207 in the treatment of acute migraine [ Time Frame: 2 hours post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	522
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK3207	Drug: MK3207 MK3207 2.5 mg taken after migraine onset.
2: Experimental MK3207	Drug: MK3207 MK3207 5 mg taken after migraine onset.
3: Experimental MK3207	Drug: MK3207 MK3207 10 mg taken after migraine onset
4: Experimental MK3207	Drug: MK3207 MK3207 20 mg taken after migraine onset.
5: Experimental MK3207	Drug: MK3207 MK3207 50 mg taken after migraine onset.
6: Experimental MK3207	Drug: MK3207 MK3207 100 mg taken after migraine onset.
7: Placebo Comparator Placebo	Drug: Comparator: placebo (unspecified) Placebo taken after migraine onsent.

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712725

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_536, MK3207-005
Study First Received:	July 8, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00712725
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009