NINDS CRC Chronic Migraine Treatment Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

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.

Key facts

Study ID

NCT00772031

Run by

Anne Lindblad

People needed

191

Starts

2008-10-01

Expected to finish

2010-09-01

Last updated by the study team

2012-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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