Last updated: June 8, 2011
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Overall Status: Completed
Phase
3
Condition
Oral Facial Pain
Chronic Pain
Headaches
Treatment
N/AClinical Study ID
NCT00210821
CR004666
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Migraine headache for at least 6 months, with 3 to 12 headaches a month for theprevious 3 months
no more than 15 headache days in the previous month before study start
no heart rhythm problems or neurologic problems
women must not be pregnant and must use birth control
Exclusion
Exclusion Criteria:
Cannot have failed at least 2 previous trials of migraine prevention drugs
cannot have failed a previous trial of topiramate or amitriptyline
no cluster headaches
no migraine with aura without headache
no pain that is worse than the migraine pain
Study Design
Total Participants: 347
Study Start date:
February 01, 2004
Estimated Completion Date:
November 30, 2005