NINDS CRC Chronic Migraine Treatment Trial - Full Text View

Sponsor:	The EMMES Corporation
Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) Ortho-McNeil Janssen Scientific Affairs, LLC CRC Operations Center
Information provided by:	The EMMES Corporation
ClinicalTrials.gov Identifier:	NCT00772031

Purpose

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.

Condition	Intervention	Phase
Chronic Migraine	Drug: propranolol LA Drug: topiramate Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Topiramate Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by The EMMES Corporation:

Primary Outcome Measures:

Reduction in the number of severe headache days within a 28 day average period in six months compared to baseline [ Time Frame: Baseline (pre-randomization), months 5 and 6 post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent experiencing at least a 30 percent reduction in headache days [ Time Frame: baseline, 3 and 6 months post randomization ] [ Designated as safety issue: No ]
Change from baseline in MIDAS score at 3 and 6 months [ Time Frame: baseline, 3 and 6 months post randomization ] [ Designated as safety issue: No ]
Change from baseline in Migraine Specific Quality of Life (MSQL) score at 3 and 6 months [ Time Frame: baseline, 3 and 6 months post randomizatio ] [ Designated as safety issue: No ]
Change in baseline in Beck Depression Inventory FastScreen score at 3 and 6 months [ Time Frame: baseline, 3 and 6 months post randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Participants will receive propranolol and topiramate.	Drug: propranolol LA Propranolol LA up to 240 mg/day Drug: 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.
2: Placebo Comparator Participants will receive a placebo and topiramate.	Drug: 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. Drug: placebo an inactive substance

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772031

Contacts

Contact: Michelle Greenberg	800-305-7811	nindscrc@ninds.nih.gov
Contact: Carolyn Burke	800-305-7811	nindscrc@ninds.nih.gov

Show 69 Study Locations

Sponsors and Collaborators

The EMMES Corporation

National Institute of Neurological Disorders and Stroke (NINDS)

Ortho-McNeil Janssen Scientific Affairs, LLC

CRC Operations Center

Investigators

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

More Information

No publications provided

Responsible Party:	NINDS Clinical Research Collaboration ( Anne Lindblad, PhD, Director, NINDS CRC Operations Center )
Study ID Numbers:	08-CRC-01
Study First Received:	October 14, 2008
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00772031 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by The EMMES Corporation:

chronic migraine, migraine prevention, chronic headache

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Headache Disorders, Primary
Brain Diseases
Neuroprotective Agents
Headache Disorders
Propranolol
Migraine Disorders
Therapeutic Uses
Topiramate

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Nervous System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Adrenergic Antagonists
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010