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Trial record 60 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007670
Recruitment Status : Completed
First Posted : January 4, 2001
Last Update Posted : January 21, 2009
Glaxo Wellcome
Information provided by:
VA Office of Research and Development

Brief Summary:
New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.

Condition or disease Intervention/treatment Phase
Seizures Drug: Carbamazepine Drug: Gabapentin Drug: Lamotrigine Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: CSP #428 - Treatment of Seizures in the Elderly Population
Study Start Date : January 1998
Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Veterans 60 years of age or older who have new onset, unprovoked seizures of focal onset, with or without secondary generalization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00007670

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United States, Alabama
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
United States, California
Vamc - West Los Angeles, Los Angeles, Ca
Los Angeles, California, United States, 90073
Vamc - San Diego, San Diego, Ca
San Diego, California, United States, 92161
San Francisco VAMC
San Francisco, California, United States, 94121
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Florida
Vamc - Bay Pines, Fl
Bay Pines, Florida, United States, 33744
Gainesville VA Medical Center
Gainesville, Florida, United States, 32608-1197
Miami VA Medical Center
Miami, Florida, United States, 33125
Study Chairperson
Miami, Florida, United States, 33125
United States, Illinois
Chicago VA Medical Center (West Side)
Chicago, Illinois, United States, 60612
Edward Hines Jr. VA Hospital
Hines, Illinois, United States, 60141
United States, Louisiana
New Orleans VAMC
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston VA Medical Center
Boston, Massachusetts, United States, 02130
United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
Study Chairman
Bronx, New York, United States, 10468
United States, Oklahoma
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Vamc - Pittsburgh, Pittsburgh, Pa
Pittsburgh, Pennsylvania, United States, 15240-1001
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
US Department of Veterans Affairs
Glaxo Wellcome

Layout table for additonal information Identifier: NCT00007670     History of Changes
Other Study ID Numbers: 428
First Posted: January 4, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: February 2007
Keywords provided by VA Office of Research and Development:
seizures in the elderly
Additional relevant MeSH terms:
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Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Sodium Channel Blockers
Analgesics, Non-Narcotic