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| Sponsor: | Anne Lindblad |
|---|---|
| Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by (Responsible Party): | Anne Lindblad, 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial |
| Enrollment: | 191 |
| Study Start Date: | October 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive propranolol and topiramate.
|
Drug: propranolol LA
Propranolol LA up to 240 mg/day
Other Name: Inderal LA
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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Placebo Comparator: 2
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
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 39 Study Locations| Principal Investigator: | 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) |
More Information
| Responsible Party: | Anne Lindblad, Executive Vice President, The EMMES Corporation, The EMMES Corporation |
| ClinicalTrials.gov Identifier: | NCT00772031 History of Changes |
| Other Study ID Numbers: | 08-CRC-01, HHSN265200523641C |
| Study First Received: | October 14, 2008 |
| Results First Received: | October 18, 2011 |
| Last Updated: | January 20, 2012 |
| Health Authority: | United States: Federal Government |
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chronic migraine, migraine prevention, chronic headache |
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Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Propranolol Topiramate Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents Anticonvulsants Central Nervous System Agents Neuroprotective Agents Protective Agents Anti-Obesity Agents |