Status:
COMPLETED
NINDS CRC Chronic Migraine Treatment Trial
Lead Sponsor:
Anne Lindblad
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Chronic Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated w...
Detailed Description
Chronic migraine affects about 2 percent of all adults. Currently there are no effective preventative treatments to deal with this disabling condition. Three randomized, placebo-controlled trials foun...
Eligibility Criteria
Inclusion
- History of chronic migraine for at least 6 months
- Age ≥ 18 years and age of migraine onset 60 or younger
- EKG performed in the last 12 months
Exclusion
- Prior neuro-imaging suggesting secondary structural causes of headache
- Beck Depression Inventory FastScreen score of 13 or greater or other severe psychiatric disorder
- Contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones)
- History of kidney failure or nephrolithiasis
- A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control
- Currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month
- Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol
- Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00772031
Start Date
October 1 2008
End Date
September 1 2010
Last Update
January 24 2012
Active Locations (39)
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1
Mayo Clinic 5777 E Mayo Blvd
Phoenix, Arizona, United States, 85054
2
Paradigm Clinical, Inc. 1324 W. Prince Rd
Tuscon, Arizona, United States, 85705
3
Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B
Chico, California, United States, 95926
4
Shanti Clinical Trials, 1880 West Washington Street
Colton, California, United States, 92324