NINDS CRC Chronic Migraine Treatment Trial
- Conditions
- Chronic Migraine
- Interventions
- Registration Number
- NCT00772031
- Lead Sponsor
- Anne Lindblad
- 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 with topiramate and a placebo.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 propranolol LA Participants will receive propranolol and topiramate. 2 placebo Participants will receive a placebo and topiramate. 1 topiramate Participants will receive propranolol and topiramate. 2 topiramate Participants will receive a placebo and topiramate.
- Primary Outcome Measures
Name Time Method Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline Baseline (pre-randomization), months 5 and 6 post randomization (Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).
- Secondary Outcome Measures
Name Time Method Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days 6 months post randomization Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days 6 months Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months Baseline and 6 months Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).
Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months Baseline and 6 months MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).
Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months baseline and 6 months post randomization The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.
Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months Baseline and 6 months The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.
Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months Baseline and 6 Months The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.
Trial Locations
- Locations (39)
Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301
🇺🇸Abington, Pennsylvania, United States
ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J
🇺🇸West Chester, Ohio, United States
Guilford Neurologic Associates, 1126 North Church Street, Suite 200
🇺🇸Greensboro, North Carolina, United States
Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower
🇺🇸Dallas, Texas, United States
Mission Neurology, Research Institute Mission Hospital, 509 Biltmore
🇺🇸Asheville, North Carolina, United States
West Virginia University 1 Medical Center Dr, Box 9180
🇺🇸Morgantown, West Virginia, United States
Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302
🇺🇸Bethlehem, Pennsylvania, United States
Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101
🇺🇸South Jordan, Utah, United States
Shanti Clinical Trials, 1880 West Washington Street
🇺🇸Colton, California, United States
Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130
🇺🇸Philadelphia, Pennsylvania, United States
MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100
🇺🇸Lenexa, Kansas, United States
Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105
🇺🇸Boca Raton, 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
Trover Health System Center for Clinical Studies, 200 Clinic Drive
🇺🇸Madisonville, Kentucky, United States
Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B
🇺🇸Edison, New Jersey, United States
Montefiore Headache Center 1575 Blondell Avenue Ste 225
🇺🇸Bronx, New York, United States
Dent Neurologic Institute, 3980 Sheridan Drive
🇺🇸Amherst, New York, United States
Schenectady Neurological Consultants 1401 Union Street
🇺🇸Schenectady, New York, United States
Island Neurological Associates, PC, 824 Old Country Road
🇺🇸Plainview, New York, United States
Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B
🇺🇸Chico, California, United States
Dr. B. Abraham, P.C. 3020 Highway 124
🇺🇸Snellville, Georgia, United States
NervPro Research, 15825 Laguna Canyon Road, Suite 202
🇺🇸Irvine, California, United States
Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200
🇺🇸Hurst, Texas, United States
Southeast Clinical Research, LLC, 304 NE 1st Street
🇺🇸Chiefland, Florida, United States
New England Regional Headache Center, Inc 85 Prescott St, Ste 101
🇺🇸Worcester, Massachusetts, United States
Neurology Clinical Research, Inc, 3540 North Pine Island Rd
🇺🇸Sunrise, Florida, United States
New England Center for Clinical Research (NECCR), 52 Brigham St #7
🇺🇸New Bedford, Massachusetts, United States
Ft. Wayne Neurological Center 7956 W. Jefferson Blvd.
🇺🇸Ft. Wayne, Indiana, United States
Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002
🇺🇸La Crosse, Wisconsin, United States
Progress Clinical Trials, 707 Kings Lane
🇺🇸Tullahoma, Tennessee, United States
Paradigm Clinical, Inc. 1324 W. Prince Rd
🇺🇸Tuscon, Arizona, United States
Mayo Clinic 5777 E Mayo Blvd
🇺🇸Phoenix, Arizona, United States
Mercy Medical Group- CHWMF 3000 Q Street, Neurology
🇺🇸Sacramento, California, United States
Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417
🇺🇸Miami, Florida, United States
ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M
🇺🇸Ann Arbor, Michigan, United States
Houston Headache Clinic, 1213 Hermann Drive, Suite 820
🇺🇸Houston, Texas, United States
Swedish Pain & Headache Center 101 Madison St, Suite 200
🇺🇸Seattle, Washington, United States
Houston Sleep Center, Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525
🇺🇸Houston, Texas, United States