NINDS CRC Chronic Migraine Treatment Trial

NCT00772031 | Completed Phase 3 Results DMC

• 2 other identifiers: 08-CRC-01HHSN265200523641C
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 39

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.

Conditions

Chronic Migraine

Keywords

chronic migraine, migraine prevention, chronic headache

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

• Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months

  Baseline and 6 months

• Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months

  baseline and 6 months post randomization

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive propranolol and topiramate.

Drug: propranolol LA; Drug: topiramate

2

PLACEBO COMPARATOR

Participants will receive a placebo and topiramate.

Drug: topiramate; Drug: placebo

Interventions

propranolol LA DRUG

Propranolol LA up to 240 mg/day

Also known as: Inderal LA

1

topiramate DRUG

Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.

1; 2

placebo DRUG

an inactive substance

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Anne Lindblad: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (39)

Mayo Clinic 5777 E Mayo Blvd

Phoenix, Arizona, 85054, United States

Location

Paradigm Clinical, Inc. 1324 W. Prince Rd

Tuscon, Arizona, 85705, United States

Location

Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B

Chico, California, 95926, United States

Location

Shanti Clinical Trials, 1880 West Washington Street

Colton, California, 92324, United States

Location

NervPro Research, 15825 Laguna Canyon Road, Suite 202

Irvine, California, 92618, United States

Location

Mercy Medical Group- CHWMF 3000 Q Street, Neurology

Sacramento, California, 95816, United States

Location

Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105

Boca Raton, Florida, 33432, United States

Location

Southeast Clinical Research, LLC, 304 NE 1st Street

Chiefland, Florida, 32626, United States

Location

Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417

Miami, Florida, 33161, United States

Location

Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B

Ormond Beach, Florida, 32174, United States

Location

Neurologique Foundation, Inc. 6 Fairfield Blvd. Suite 11

Ponte Vedra, Florida, 32082, United States

Location

Neurology Clinical Research, Inc, 3540 North Pine Island Rd

Sunrise, Florida, 33351, United States

Location

Dr. B. Abraham, P.C. 3020 Highway 124

Snellville, Georgia, 30039, United States

Location

Ft. Wayne Neurological Center 7956 W. Jefferson Blvd.

Fort Wayne, Indiana, 46804, United States

Location

MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100

Lenexa, Kansas, 66214, United States

Location

Trover Health System Center for Clinical Studies, 200 Clinic Drive

Madisonville, Kentucky, 42431, United States

Location

New England Center for Clinical Research (NECCR), 52 Brigham St #7

New Bedford, Massachusetts, 02740, United States

Location

New England Regional Headache Center, Inc 85 Prescott St, Ste 101

Worcester, Massachusetts, 01605-2982, United States

Location

ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M

Ann Arbor, Michigan, 48106, United States

Location

Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B

Edison, New Jersey, 08817, United States

Location

Dent Neurologic Institute, 3980 Sheridan Drive

Amherst, New York, 14226, United States

Location

Island Neurological Associates, PC, 824 Old Country Road

Plainview, New York, 11803, United States

Location

Schenectady Neurological Consultants 1401 Union Street

Schenectady, New York, 12308, United States

Location

Montefiore Headache Center 1575 Blondell Avenue Ste 225

The Bronx, New York, 10461, United States

Location

Mission Neurology, Research Institute Mission Hospital, 509 Biltmore

Asheville, North Carolina, 28801, United States

Location

Guilford Neurologic Associates, 1126 North Church Street, Suite 200

Greensboro, North Carolina, 27401, United States

Location

ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J

West Chester, Ohio, 45069, United States

Location

Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301

Abington, Pennsylvania, 19001, United States

Location

Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302

Bethlehem, Pennsylvania, 18015, United States

Location

Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130

Philadelphia, Pennsylvania, 19107, United States

Location

Progress Clinical Trials, 707 Kings Lane

Tullahoma, Tennessee, 37388, United States

Location

Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower

Dallas, Texas, 75214, United States

Location

Houston Headache Clinic, 1213 Hermann Drive, Suite 820

Houston, Texas, 77004, United States

Location

Houston Sleep Center, Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525

Houston, Texas, 77063, United States

Location

Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200

Hurst, Texas, 76054, United States

Location

Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101

South Jordan, Utah, 84095, United States

Location

Swedish Pain & Headache Center 101 Madison St, Suite 200

Seattle, Washington, 98116, United States

Location

West Virginia University 1 Medical Center Dr, Box 9180

Morgantown, West Virginia, 26506 - 9180, United States

Location

Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Headache Disorders

Interventions

Propranolol; Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Anne S Lindblad, PhD
• Organization: The EMMES Corporation

alindblad@emmes.com

301 251 1161

Study Officials

• David Dodick, MD

  Professor of Neurology, Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Stephen D. Silberstein, MD

  Professor of Neurology, Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Deborah Hirtz, MD

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Vice President, The EMMES Corporation

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 15, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 24, 2012
• Results First Posted: January 19, 2012

Record last verified: 2012-01

Locations

US (39)