Status:
COMPLETED
Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
Lead Sponsor:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether Topiramate is effective in preventing the development of chronic daily headache among patients with episodic migraine headaches.
Detailed Description
Chronic daily headache encompasses a frequent headache state in which the increased burden of pain further compromises quality of life and adversely impacts patients, their families, and health care p...
Eligibility Criteria
Inclusion
- To qualify for this study you must be 18-65 years old
- have a history of migraine headaches for at least 1 year
- experience at least 10 but less than 15 migraine headache days and less than 15 total headache days/month
- able to take oral medication
- able to understand and sign the informed consent and to complete headache diaries.
Exclusion
- You will not be able to participate in the study if you previously discontinued Topiramate because it did not make you feel better or it made you feel different
- have migraine aura without headache
- have a positive urine drug screen
- have a history of kidney stones
- have a history of suicide attempt
- pregnant females
- already on a migraine preventive medicine.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00212810
Start Date
September 1 2005
End Date
August 1 2007
Last Update
May 19 2011
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