NINDS CRC Chronic Migraine Treatment Trial

Chronic Migraine Clinical Trial

— CMTT  

Official title:

NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772031
• Other study ID #: 08-CRC-01
• Secondary ID: HHSN265200523641
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2008
• Last updated: January 20, 2012
• Start date: October 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2012
• Source: The EMMES Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301	Abington	Pennsylvania
United States	Dent Neurologic Institute, 3980 Sheridan Drive	Amherst	New York
United States	ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M	Ann Arbor	Michigan
United States	Mission Neurology, Research Institute Mission Hospital, 509 Biltmore	Asheville	North Carolina
United States	Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302	Bethlehem	Pennsylvania
United States	Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105	Boca Raton	Florida
United States	Montefiore Headache Center 1575 Blondell Avenue Ste 225	Bronx	New York
United States	Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B	Chico	California
United States	Southeast Clinical Research, LLC, 304 NE 1st Street	Chiefland	Florida
United States	Shanti Clinical Trials, 1880 West Washington Street	Colton	California
United States	Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower	Dallas	Texas
United States	Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B	Edison	New Jersey
United States	Ft. Wayne Neurological Center 7956 W. Jefferson Blvd.	Ft. Wayne	Indiana
United States	Guilford Neurologic Associates, 1126 North Church Street, Suite 200	Greensboro	North Carolina
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	NervPro Research, 15825 Laguna Canyon Road, Suite 202	Irvine	California
United States	Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002	La Crosse	Wisconsin
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	Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417	Miami	Florida
United States	West Virginia University 1 Medical Center Dr, Box 9180	Morgantown	West Virginia
United States	New England Center for Clinical Research (NECCR), 52 Brigham St #7	New Bedford	Massachusetts
United States	Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B	Ormond Beach	Florida
United States	Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130	Philadelphia	Pennsylvania
United States	Mayo Clinic 5777 E Mayo Blvd	Phoenix	Arizona
United States	Island Neurological Associates, PC, 824 Old Country Road	Plainview	New York
United States	Neurologique Foundation, Inc. 6 Fairfield Blvd. Suite 11	Ponte Vedra	Florida
United States	Mercy Medical Group- CHWMF 3000 Q Street, Neurology	Sacramento	California
United States	Schenectady Neurological Consultants 1401 Union Street	Schenectady	New York
United States	Swedish Pain & Headache Center 101 Madison St, Suite 200	Seattle	Washington
United States	Dr. B. Abraham, P.C. 3020 Highway 124	Snellville	Georgia
United States	Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101	South Jordan	Utah
United States	Neurology Clinical Research, Inc, 3540 North Pine Island Rd	Sunrise	Florida
United States	Progress Clinical Trials, 707 Kings Lane	Tullahoma	Tennessee
United States	Paradigm Clinical, Inc. 1324 W. Prince Rd	Tuscon	Arizona
United States	ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J	West Chester	Ohio
United States	New England Regional Headache Center, Inc 85 Prescott St, Ste 101	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Anne Lindblad	National Institute of Neurological Disorders and Stroke (NINDS), Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline	(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).	Baseline (pre-randomization), months 5 and 6 post randomization	No
Secondary	Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days		6 months post randomization	No
Secondary	Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days		6 months	No
Secondary	Change From Baseline in Beck's Depression Inventory FastScreen Score at 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).	Baseline and 6 months	Yes
Secondary	Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 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).	Baseline and 6 months	No
Secondary	Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 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.	baseline and 6 months post randomization	No
Secondary	Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 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.	Baseline and 6 months	No
Secondary	Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 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.	Baseline and 6 Months	No