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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Collaborators: |
Parke-Davis Glaxo Wellcome |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00007670 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Seizures |
Drug: Carbamazepine Drug: Gabapentin Drug: Lamotrigine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | CSP #428 - Treatment of Seizures in the Elderly Population |
| Estimated Enrollment: | 720 |
| Study Start Date: | January 1998 |
| Estimated Study Completion Date: | March 2003 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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 | |
| Study Chairperson | |
| Miami, Florida, United States, 33125 | |
| Miami VA Medical Center | |
| 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 | |
| Study Chairman | |
| Bronx, New York, United States, 10468 | |
| Bronx VA Medical Center | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00007670 History of Changes |
| Other Study ID Numbers: | 428 |
| Study First Received: | December 29, 2000 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Federal Government |
|
gabapentin lamotrigine seizures in the elderly Carbamazepine |
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Carbamazepine Gabapentin Lamotrigine Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents |