NINDS CRC Chronic Migraine Treatment Trial

Condition(s) targeted: Chronic Migraine

Intervention: propranolol LA (Drug); topiramate (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: The EMMES Corporation

Official(s) and/or principal investigator(s):
David Dodick, MD, Principal Investigator, Affiliation: Professor of Neurology, Mayo Clinic
Stephen D. Silberstein, MD, Principal Investigator, Affiliation: Professor of Neurology, Thomas Jefferson University
Richard Lipton, MD, Principal Investigator, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Deborah Hirtz, MD, Principal Investigator, Affiliation: National Institute of Neurological Disorders and Stroke (NINDS)

Overall contact:
Michelle Greenberg, Phone: 800-305-7811, Email: nindscrc@ninds.nih.gov

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.

Official title: NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Reduction in the number of severe headache days within a 28 day average period in six months compared to baseline

Secondary outcome:

Percent experiencing at least a 30 percent reduction in headache days

Change from baseline in MIDAS score at 3 and 6 months

Change from baseline in Migraine Specific Quality of Life (MSQL) score at 3 and 6 months

Change in baseline in Beck Depression Inventory FastScreen score at 3 and 6 months

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Michelle Greenberg, Phone: 800-305-7811, Email: nindscrc@ninds.nih.gov

Apex Clinical Trials - Greystone Neuro, 1528 Carraway Blvd., Suite 1000, Birmingham, Alabama 35234, United States; Recruiting
Megan Ford, Phone: 205-991-3300, Email: apex@apexcti.com
Hisham Hakim, MD, Principal Investigator

Foothills Neurology, 4530 East Muirwood Drive, Suite 111, Phoenix, Arizona 85048, United States; Recruiting
Leigh Gressley, Phone: 480-961-2365, Email: lgressley@foothillsneurology.com
Stuart Hetrick, MD, Principal Investigator

HOPE Research Institute LLC, 3120 E. Union Hills Drive, Phoenix, Arizona 85050, United States; Recruiting
Lisa Rumble, Phone: 602-288-4673, Email: lisa.rumble@hriaz.com
Jeffery Gitt, Principal Investigator

Mayo Clinic 5777 E Mayo Blvd, Phoenix, Arizona 85054, United States; Recruiting
Tamera Le Mene, RN, Phone: 480-342-2942, Email: lemene.tamera@mayo.edu
Cynthia Kocinski, Phone: 480-342-3078, Email: kocinski.cynthia@mayo.edu
David W. Dodick, MD, Principal Investigator

Paradigm Clinical, Inc. 1324 W. Prince Rd, Tuscon, Arizona 85705, United States; Recruiting
Kim Tschida, Phone: 520-829-6675, Email: ktschida@paradigmclinical.com
David Wilson, Phone: 520-829-6675, Email: dwilson@paradigmclinical.com
Pamela Laubscher, D.O., Principal Investigator

Neurological Associates, PL, 1794 E Joyce Blvd., # 3, P O Box 9990, Fayetteville, Arkansas 72703, United States; Withdrawn

Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B, Chico, California 95926, United States; Recruiting
Rosemarie Knispek, Phone: 530-894-3330, Email: rosemarie.forner@comcast.net
Stephen David Forner, MD, Principal Investigator

Shanti Clinical Trials, 1880 West Washington Street, Colton, California 92324, United States; Recruiting
Satish M. Sood, PhD, Phone: 909-423-0367, Email: pa@sleepcenteroc.com
Malwinder K. Multani, MD, Principal Investigator

Fullerton Neurology and Headache Center 100 Laguna Rd. # 208, Fullerton, California 92835, United States; Recruiting
Alexandra Vasquez, Phone: 714-738-0800, Email: alexandra_vasquez@sbcglobal.net
Kellie Simpson, M.S., N.P., Phone: 714-738-0800, Email: kellie_simpson@sbcglobal.net
Jack Florin, M.D., Principal Investigator

NervPro Research, 15825 Laguna Canyon Road, Suite 202, Irvine, California 92618, United States; Recruiting
Krisma Montalvo, Phone: 949-753-1570, Email: kmontalvo@nervepro.com
Bruce Cleeremans, MD, Principal Investigator

Sleep Center Orange County, 4980 Barranca Parkway, Suite 170, Irvine, California 92604, United States; Recruiting
Ellie Moritake, PA-C, Phone: 949-679-5510, Email: pa@sleepcenteroc.com
Wesley Fleming, MD, Principal Investigator

Scripps Clinic 10666 N Torrey Pines Rd, La Jolla, California 92037, United States; Recruiting
Crystal Sanchez, Phone: 858-554-5540, Email: sanchez.crystal@scrippshealth.org
Christy Jackson, M.D., Principal Investigator

SOMA Orthopedics Medical Group, 318 West Viento Street, Tracy, California 95391, United States; Recruiting
Moshe Lewis, MD, Phone: 857-222-5585, Email: mosha19@yahoo.com
Moshe Lewis, MD, Principal Investigator

Neurological Research Institute of the East Bay 1844 San Miguel, # 316, Walnut Creek, California 94596, United States; Recruiting
Michael Stein, MD, Phone: 925-938-5252, Email: neurology2@gmail.com
Michael Stein, MD, Principal Investigator

Joey Robert Gee, DO, 26800 Crown Valley Pkwy, Suite 100, Mission Viejo, California 92691, United States; Recruiting
Joey R. Gee, DO, Phone: 949-542-8002, Email: jgee@mimg.com
Joey R. Gee, D.O., Principal Investigator

Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105, Boca Raton, Florida 33432, United States; Recruiting
Alis Quinn, Phone: 561-715-7032, Email: alieden@comcast.net
Gregory Marsella, MD, Principal Investigator

Naples Institute for Clinical Research, 3376 Woods Edge Circle, Suite 102, Bonita Springs, Florida 34134, United States; Recruiting
Emilio Munoz, MD, PhD, Phone: 239-390-0329, Email: emunoz@naplesclinicalresearch.com
Leonard Lado, MD, Principal Investigator

Southeast Clinical Research, LLC, 304 NE 1st Street, Chiefland, Florida 32626, United States; Recruiting
Shannon Cooper, Phone: 352-490-4816, Email: southeastclinic@bellsouth.net
Donn Keels, MD, Principal Investigator

Homestead Clinical Research, 27501 South Dixie Highway, Suite #200, Homestead, Florida 33032, United States; Recruiting
Bianca Fajardo, Phone: 305-246-4468, Email: bmf0125@hotmail.com
Hector Maldonado, MD, Principal Investigator

Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417, Miami, Florida 33161, United States; Recruiting
Gustavo Rodriguez, Phone: 305-722-8444, Ext: 2260, Email: grodriguez@segalinstitute.com
Scott Segal, MD, Principal Investigator

Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B, Ormond Beach, Florida 32174, United States; Recruiting
Sandra Geyer, Phone: 386-673-2500, Ext: 248, Email: neurosgeyer@yahoo.com
James Scott, MD, Principal Investigator

Florida Center for Headache & Neurology, 10377 S US Highway 1, Ste 104, Port St. Lucie, Florida 34952, United States; Recruiting
Sofia Conidi, Phone: 772-337-7272, Email: fxneuro@bellsouth.net
Frank Conidi, MD, Principal Investigator

Neurology Clinical Research, Inc, 3540 North Pine Island Rd, Sunrise, Florida 33351, United States; Recruiting
Christine M Lepurage, Phone: 954-475-8171, Email: clepurage@neuroresearch.net
Fanny Gully, Phone: 954-475-8171, Email: fgully@neuroresearch.net
Richard P. Singer, MD, Principal Investigator

Laszlo Mate, MD, 927 45th Street, Suite 105 FL, West Palm Beach, Florida 33407 - 2450, United States; Recruiting
Mary Sergalis, LPN, Phone: 561-882-0088, Email: sergalis@bellsouth.net
Laszlo Mate, MD, Principal Investigator

Dr. B. Abraham, P.C. 3020 Highway 124, Snellville, Georgia 30039, United States; Recruiting
Kim Turner, Phone: 770-978-1331, Email: kturner@drbabrahampc.com
Patricia Barrington, DO, Principal Investigator

Diamond Headache Clinic, 467 W Deming Place, Suite 500, Chicago, Illinois 60614, United States; Recruiting
Frederick Freitag, MD, Phone: 773-388-6390
Frederick Freitag, MD, Principal Investigator

Tri-City Neurology, SC, 2210 Dean St., Suite D, Saint Charles, Illinois 60175, United States; Recruiting
Nicholas Schlageter, Phone: 630-587-2068, Email: mschlageter@msn.com
Nicholas Schlageter, MD, Principal Investigator

Methodist Medical Group, Clinical Research Dept., 9202 E 116th Street, Indianapolis, Indiana 46037, United States; Recruiting
Tara Seale, Phone: 317-577-0490, Email: tseale@clarian.org
Sean Keller, MD, Principal Investigator

Associates in Neurology, P.C., 2000 Roosevelt Rd, Suite 201,, Valparaiso, Indiana 46383, United States; Recruiting
Carol L. Parks, Phone: 219-476-7777, Email: cparks@associatesinneurology.com
Richard H. Strawsburg, M.D., Principal Investigator

MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100, Lenexa, Kansas 66214, United States; Recruiting
Laurie Kemble, BHS, CRC, Phone: 913-894-1500, Ext: 166, Email: lkemble@neurokc.com
Dana M. Winegarner, DO, Principal Investigator

Univ of Louisville Kentucky Neuroscience Research 401 East Chestnut St Ste 520, Louisville, Kentucky 40202, United States; Recruiting
Ronald Smith, Phone: 502-589-6990, Email: rssmit08@louisville.edu
Michael K. Sowell, MD, Principal Investigator

Trover Health System Center for Clinical Studies, 200 Clinic Drive, Madisonville, Kentucky 42431, United States; Recruiting
Valarie Bryant, RN, Phone: 270-825-6681, Email: vbryant@trover.org
Naghma Mufti, MD, Principal Investigator

Dr. Steven Zuckerman, 7922 Summa Avenue, #A4, Baton Rouge, Louisiana 70809, United States; Recruiting
Michelle Hurst, Phone: 225-341-8311, Email: michelle@brcoxmail.com
Steven Zuckerman, MD, Principal Investigator

New England Center for Clinical Research (NECCR), 52 Brigham St #7, New Bedford, Massachusetts 02740, United States; Recruiting
Luis A Torres, Phone: 508-208-1437, Email: ltorres@neccr.com
Donna Ford, Phone: 508 - 999 - 5800, Email: dford@neccr.com
Gregory G Allen, Jr., DO, Principal Investigator

MedVadis Research Corp, 25 Walnut Street, Suite #400, Wellesley Hills, Massachusetts 02481-2150, United States; Recruiting
Kirsten Finn, Phone: 781-431-1113, Email: finn@medvadis.com
Nancy Vela, RN, Phone: 781-431-1113, Email: vela@medvadis.com
Egilius Spierings, MD, Principal Investigator

New England Regional Headache Center, Inc 85 Prescott St, Ste 101, Worcester, Massachusetts 01605-2982, United States; Recruiting
Deborah Clark, CMA, CRC, Phone: 508-890-5633, Email: deborah@nerhc.org
Herbert Markley, MD, Principal Investigator

ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M, Ann Arbor, Michigan 48106, United States; Recruiting
Tiffany Streett, Phone: 734-930-7105, Email: tiffany_streett@ihacares.com
Olav Jaren, MD, Principal Investigator

Hurley Medical Center, One Hurley Plaza-6 West Research, Flint, Michigan 48503, United States; Recruiting
Joyvina Evans, Phone: 810-424-6800, Email: joyvinaevans@hurleymc.com
Devakinanda Pasupuleti, MD, Principal Investigator

Kevin Kellogg, MD, 1675 Leahy Street, Suite 201, Muskegon, Michigan 49442, United States; Not yet recruiting
Angela Gilmore, Phone: 231-728-5870, Email: angelagilmore38@msn.com
Kevin Kellogg, MD, Principal Investigator

University of Missouri, Neurology Clinic, 5 Hospital Drive, Suite CE507, Columbia, Missouri 65212, United States; Recruiting
Annamarie Wolfe-Boyd, Phone: 573-882-8668, Email: wolfea@health.missouri.edu
Niranjan N. Singh, MD, Principal Investigator

Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B, Edison, New Jersey 08817, United States; Recruiting
Christine Piekarski, Phone: 732-287-5130, Email: cpiekarski@accrinc.com
Marcia Collins, Phone: 732 - 287 - 5130, Email: cmcollins@accrinc.com
Harry Collins, MD, Principal Investigator

Dent Neurologic Institute, 3980 Sheridan Drive, Amherst, New York 14226, United States; Recruiting
Lori Zdrojewski, Phone: 716-250-2055, Email: lzdrojewski@dentinstitute.com
Lazlo Mechtler, MD, Principal Investigator

Montefiore Headache Center 1575 Blondell Avenue Ste 225, Bronx, New York 10461, United States; Recruiting
Sarmistha Panda, Phone: 718-405-8363, Email: spanda@montefiore.org
Tiffani DeFreitas, Phone: 718-405-8007, Email: tdefreit@montefiore.org
Brian M Grosberg, MD, Principal Investigator

Island Neurological Associates, PC, 824 Old Country Road, Plainview, New York 11803, United States; Recruiting
Tiffany Harding, Phone: 516-822-2230, Email: tiffanyharding@aol.com
Ira Turner, MD, Principal Investigator

Schenectady Neurological Consultants 1401 Union Street, Schenectady, New York 12308, United States; Recruiting
Rosemary Kenitz, Phone: 518-381-9202, Email: neuroresearch1401@yahoo.com
Bruno P. Tolge, MD, Principal Investigator

Mission Neurology, Research Institute Mission Hospital, 509 Biltmore, Asheville, North Carolina 28801, United States; Recruiting
Dianne Lancaster, Phone: 828-213-7009, Email: dianne.lancaster@msj.org
Jennifer Jones, MD, Principal Investigator

High Country Neurology, 400 Shadowline Dr., Suite 202, Boone, North Carolina 286007, United States; Recruiting
Shannon Stout, Phone: 828-262-0600, Email: sjohnson@highcountryneurology.com
Jeffrey Crittenden, MD, Principal Investigator

Carolina Headache Institute, PLLC, 55 Vilcom Center, Suite 110, Chapel Hill, North Carolina 27514, United States; Recruiting
Sutapa Ford, PhD, Phone: 909-423-0367, Email: s.sood@hotmail.com
Anne Calhoun, MD, Principal Investigator

Guilford Neurologic Associates, 1126 North Church Street, Suite 200, Greensboro, North Carolina 27401, United States; Recruiting
Patricia Henderson, CRC, Phone: 336-273-2511, Email: phenderson@guilfordneurologic.com
Michael Reynolds, MD, Principal Investigator

New Albany Surgical Hospital Foundation, 7277 Smith's Mill Road, Suite 300, New Albany, Ohio 43054, United States; Recruiting
Connie Cottrell, RN, Phone: 614-839-3254, Email: cottrell@rrohio.com
Martin Taylor, MD, Principal Investigator

ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J, West Chester, Ohio 45069, United States; Recruiting
Kathy Booth, Phone: 513-777-2543, Email: clinexcellead@live.com
Jennifer Shoker, Phone: 513-777-2543, Email: jennyshoker@headacheassociates.com
David Ellison, MD, Principal Investigator

New Albany Surgical Hospital Foundation/OrthoNeuro, Inc., 70 S. Cleveland Ave., Westerville, Ohio 43081, United States; Recruiting
Francis O'Donnell, MD, Phone: 614-890-6555
Francis O'Donnell, MD, Principal Investigator

Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301, Abington, Pennsylvania 19001, United States; Recruiting
Jennifer McGowan, Phone: 215-886-7000, Email: jmtrainer20@gmail.com
Brad Klein, MD, Principal Investigator

Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302, Bethlehem, Pennsylvania 18015, United States; Recruiting
Jasmin Nuesa, Phone: 610-866-6614, Email: neurorc@gmail.com
Jeffrey Gould, MD, Principal Investigator

Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130, Philadelphia, Pennsylvania 19107, United States; Recruiting
Kathleen Bradley, Phone: 215-955-2025, Email: kathleen.bradley@jefferson.edu
Stephen D. Silberstein, MD, Principal Investigator

CNS Research Inc. 16 Haliburton Road, East Providence, Rhode Island 02916, United States; Recruiting
Patricia Epple, RN, BS, CCRC, Phone: 800-707-6013, Email: patricia@cns-research.com
Norman Gordon, MD, Principal Investigator

Neurological Medicine, 311 Landrum Place #B400, Clarksville, Tennessee 37043, United States; Recruiting
Deborah Williams, Phone: 931-647-2828, Email: dmwilliamsNPC@aol.com
Karen Stell, Phone: 931-647-2828, Email: kgstell@aol.com
Constance Johnson, MD, Principal Investigator

Progress Clinical Trials, 707 Kings Lane, Tullahoma, Tennessee 37388, United States; Recruiting
Roberta Rynearson, Phone: 931-461-0131, Email: tnclinicaltrials@gmail.com
Raghu Upender, MD, Principal Investigator

Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower, Dallas, Texas 75214, United States; Recruiting
Shari L. Hand, BA, CCRC, Phone: 214-279-0326, Email: shand@texasneurology.com
Steven P Herzog, MD, Principal Investigator

ACS ProHealth Services, Inc., 7111 Harwin Drive 272, Houston, Texas 77036, United States; Withdrawn

Houston Headache Clinic, 1213 Hermann Drive, Suite 820, Houston, Texas 77004, United States; Recruiting
Shehla Barlas, Phone: 713-528-1916, Email: shehlab@houstonheadacheclinic.com
Ninan Matthew, MD, Principal Investigator

Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525, Houston, Texas 77063, United States; Recruiting
Erin Dallas, Phone: 713-465-7066, Email: edallas@houstonsleepcenter.com
Todd Swick, MD, Principal Investigator

Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200, Hurst, Texas 76054, United States; Recruiting
Christi Kelly, Phone: 817-281-4156, Email: christi@texasfamilicare.com
Robert A. Strzinek, DO, Principal Investigator

Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101, South Jordan, Utah 84095, United States; Recruiting
Laura Allen, Phone: 801-891-0544, Email: ljallen@sleepiu.com
Andrew Gasecki, MD, Principal Investigator

Swedish Pain & Headache Center 101 Madison St, Suite 200, Seattle, Washington 98116, United States; Recruiting
Pat Barrodale, RN, Phone: 206-215-3502, Email: pat.barrodale@swedish.org
Sheena K Aurora, MD, Principal Investigator

West Virginia University 1 Medical Center Dr, Box 9180, Morgantown, West Virginia 26506 - 9180, United States; Recruiting
Patricia Altemus, Phone: 304-598-4000, Email: paltemus@hsc.wvu.edu
David Watson, MD, Principal Investigator

Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002, La Crosse, Wisconsin 54601, United States; Recruiting
Diane Webster, RN, Phone: 608-775-2492, Email: djwebste@gundluth.org
Richard Hutter, MD, Principal Investigator

Starting date: October 2008
Ending date: December 2009
Last updated: September 22, 2009