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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00772031 |
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 |
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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 |
Estimated Enrollment: | 250 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive propranolol and topiramate.
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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.
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2: Placebo Comparator
Participants will receive a placebo and topiramate.
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michelle Greenberg | 800-305-7811 | nindscrc@ninds.nih.gov |
Contact: Carolyn Burke | 800-305-7811 | nindscrc@ninds.nih.gov |
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 |
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: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00772031 |
Health Authority: | United States: Federal Government |
chronic migraine, migraine prevention, chronic headache |
Propranolol Migraine Disorders Headache Topiramate |
Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Headache Disorders |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Protective Agents |
Neuroprotective Agents Pharmacologic Actions Anti-Obesity Agents Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |