Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
191 participants
INTERVENTIONAL
2008-10-31
2010-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Participants will receive propranolol and topiramate.
propranolol LA
Propranolol LA up to 240 mg/day
topiramate
Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.
2
Participants will receive a placebo and topiramate.
topiramate
Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.
placebo
an inactive substance
Interventions
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propranolol LA
Propranolol LA up to 240 mg/day
topiramate
Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.
placebo
an inactive substance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years and age of migraine onset 60 or younger
* EKG performed in the last 12 months
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Ortho-McNeil Janssen Scientific Affairs, LLC
INDUSTRY
Anne Lindblad
INDUSTRY
Responsible Party
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Anne Lindblad
Executive Vice President, The EMMES Corporation
Principal Investigators
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David Dodick, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Neurology, Mayo Clinic
Stephen D. Silberstein, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Neurology, Thomas Jefferson University
Deborah Hirtz, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
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Mayo Clinic 5777 E Mayo Blvd
Phoenix, Arizona, United States
Paradigm Clinical, Inc. 1324 W. Prince Rd
Tuscon, Arizona, United States
Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B
Chico, California, United States
Shanti Clinical Trials, 1880 West Washington Street
Colton, California, United States
NervPro Research, 15825 Laguna Canyon Road, Suite 202
Irvine, California, United States
Mercy Medical Group- CHWMF 3000 Q Street, Neurology
Sacramento, California, United States
Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105
Boca Raton, Florida, United States
Southeast Clinical Research, LLC, 304 NE 1st Street
Chiefland, Florida, United States
Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417
Miami, Florida, United States
Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B
Ormond Beach, Florida, United States
Neurologique Foundation, Inc. 6 Fairfield Blvd. Suite 11
Ponte Vedra, Florida, United States
Neurology Clinical Research, Inc, 3540 North Pine Island Rd
Sunrise, Florida, United States
Dr. B. Abraham, P.C. 3020 Highway 124
Snellville, Georgia, United States
Ft. Wayne Neurological Center 7956 W. Jefferson Blvd.
Fort Wayne, Indiana, United States
MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100
Lenexa, Kansas, United States
Trover Health System Center for Clinical Studies, 200 Clinic Drive
Madisonville, Kentucky, United States
New England Center for Clinical Research (NECCR), 52 Brigham St #7
New Bedford, Massachusetts, United States
New England Regional Headache Center, Inc 85 Prescott St, Ste 101
Worcester, Massachusetts, United States
ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M
Ann Arbor, Michigan, United States
Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B
Edison, New Jersey, United States
Dent Neurologic Institute, 3980 Sheridan Drive
Amherst, New York, United States
Island Neurological Associates, PC, 824 Old Country Road
Plainview, New York, United States
Schenectady Neurological Consultants 1401 Union Street
Schenectady, New York, United States
Montefiore Headache Center 1575 Blondell Avenue Ste 225
The Bronx, New York, United States
Mission Neurology, Research Institute Mission Hospital, 509 Biltmore
Asheville, North Carolina, United States
Guilford Neurologic Associates, 1126 North Church Street, Suite 200
Greensboro, North Carolina, United States
ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J
West Chester, Ohio, United States
Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301
Abington, Pennsylvania, United States
Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302
Bethlehem, Pennsylvania, United States
Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130
Philadelphia, Pennsylvania, United States
Progress Clinical Trials, 707 Kings Lane
Tullahoma, Tennessee, United States
Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower
Dallas, Texas, United States
Houston Headache Clinic, 1213 Hermann Drive, Suite 820
Houston, Texas, United States
Houston Sleep Center, Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525
Houston, Texas, United States
Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200
Hurst, Texas, United States
Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101
South Jordan, Utah, United States
Swedish Pain & Headache Center 101 Madison St, Suite 200
Seattle, Washington, United States
West Virginia University 1 Medical Center Dr, Box 9180
Morgantown, West Virginia, United States
Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002
La Crosse, Wisconsin, United States
Countries
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Other Identifiers
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HHSN265200523641C
Identifier Type: OTHER
Identifier Source: secondary_id
08-CRC-01
Identifier Type: -
Identifier Source: org_study_id
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