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NINDS CRC Chronic Migraine Treatment Trial - NCT00772031-11803(Clinical Trial 247332)



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City:  Plainview
State:  
NY
Zip Code: 11803
Conditions: Chronic Migraine
Purpose: 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 with topiramate and a placebo.
Study summary: 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 found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. As a result of these trials, topiramate is becoming the standard treatment among headache specialists. Experts agree that treatment with combinations of preventive agents is required in the majority of individuals with chronic migraine for maximal headache relief. No randomized trials have assessed the value of frequently used combinations of preventive agents for chronic migraine. The goal of this trial is to determine if adding a second drug to topiramate treatment will further reduce the headache burden for people with this condition. In the study, 250 participants with chronic migraine will be randomized to two groups - treatment with topiramate and propranolol or topiramate and placebo. Participants will be followed for six months.
Criteria: Inclusion Criteria: - 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 Criteria: - 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
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Data Source: ClinicalTrials.gov
Date Processed: September 9, 2010
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