Clinical trial NCT00772031: NINDS CRC Chronic Migraine Treatment Trial
Official title: NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Migraine
Keywords: chronic migraine, migraine prevention, chronic headache
Lead sponsor: The Emmes Company, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2008-10-15
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline
timeFrame: Baseline (pre-randomization), months 5 and 6 post randomization
Secondary outcomes:
measure: Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days
timeFrame: 6 months post randomization
measure: Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days
timeFrame: 6 months
measure: Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months
timeFrame: baseline and 6 months post randomization
measure: Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months
timeFrame: Baseline and 6 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic 5777 E Mayo Blvd
state: Arizona
city: Tuscon
country: United States
facility: Paradigm Clinical, Inc. 1324 W. Prince Rd
state: Arizona
city: Chico
country: United States
facility: Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B
state: California
city: Colton
country: United States
facility: Shanti Clinical Trials, 1880 West Washington Street
state: California
city: Irvine
country: United States
facility: NervPro Research, 15825 Laguna Canyon Road, Suite 202
state: California
city: Sacramento
country: United States
facility: Mercy Medical Group- CHWMF 3000 Q Street, Neurology
state: California
city: Boca Raton
country: United States
facility: Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105
state: Florida
city: Chiefland
country: United States
facility: Southeast Clinical Research, LLC, 304 NE 1st Street
state: Florida
city: Miami
country: United States
facility: Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B
state: Florida
city: Ponte Vedra
country: United States
facility: Neurologique Foundation, Inc. 6 Fairfield Blvd. Suite 11
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research, Inc, 3540 North Pine Island Rd
state: Florida
city: Snellville
country: United States
facility: Dr. B. Abraham, P.C. 3020 Highway 124
state: Georgia
city: Ft. Wayne
country: United States
facility: Ft. Wayne Neurological Center 7956 W. Jefferson Blvd.
state: Indiana
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100
state: Kansas
city: Madisonville
country: United States
facility: Trover Health System Center for Clinical Studies, 200 Clinic Drive
state: Kentucky
city: New Bedford
country: United States
facility: New England Center for Clinical Research (NECCR), 52 Brigham St #7
state: Massachusetts
city: Worcester
country: United States
facility: New England Regional Headache Center, Inc 85 Prescott St, Ste 101
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M
state: Michigan
city: Edison
country: United States
facility: Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute, 3980 Sheridan Drive
state: New York
city: Bronx
country: United States
facility: Montefiore Headache Center 1575 Blondell Avenue Ste 225
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates, PC, 824 Old Country Road
state: New York
city: Schenectady
country: United States
facility: Schenectady Neurological Consultants 1401 Union Street
state: New York
city: Asheville
country: United States
facility: Mission Neurology, Research Institute Mission Hospital, 509 Biltmore
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associates, 1126 North Church Street, Suite 200
state: North Carolina
city: West Chester
country: United States
facility: ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301
state: Pennsylvania
city: Bethlehem
country: United States
facility: Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130
state: Pennsylvania
city: Tullahoma
country: United States
facility: Progress Clinical Trials, 707 Kings Lane
state: Tennessee
city: Dallas
country: United States
facility: Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower
state: Texas
city: Houston
country: United States
facility: Houston Headache Clinic, 1213 Hermann Drive, Suite 820
state: Texas
city: Houston
country: United States
facility: Houston Sleep Center, Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200
state: Texas
city: South Jordan
country: United States
facility: Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101
state: Utah
city: Seattle
country: United States
facility: Swedish Pain & Headache Center 101 Madison St, Suite 200
state: Washington
city: Morgantown
country: United States
facility: West Virginia University 1 Medical Center Dr, Box 9180
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002
state: Wisconsin
Study officials:
affiliation: Professor of Neurology, Mayo Clinic
name: David Dodick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Neurology, Thomas Jefferson University
name: Stephen D. Silberstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Deborah Hirtz, MD
role: PRINCIPAL_INVESTIGATOR
References: