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.
CSP #428 - Treatment of Seizures in the Elderly Population
1 other identifier
interventional
720
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 1998
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
December 29, 2000
CompletedFirst Posted
Study publicly available on registry
January 4, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedOctober 30, 2023
October 1, 2023
December 29, 2000
October 26, 2023
Conditions
Keywords
Interventions
Eligibility Criteria
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Sponsors & Collaborators
- US Department of Veterans Affairslead
- Parke-Daviscollaborator
- Glaxo Wellcomecollaborator
Study Sites (20)
Birmingham VA Medical Center
Birmingham, Alabama, 35233, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Vamc - West Los Angeles, Los Angeles, Ca
Los Angeles, California, 90073, United States
Vamc - San Diego, San Diego, Ca
San Diego, California, 92161, United States
San Francisco VAMC
San Francisco, California, 94121, United States
Denver VA Medical Center
Denver, Colorado, 80220, United States
Vamc - Bay Pines, Fl
Bay Pines, Florida, 33744, United States
Gainesville VA Medical Center
Gainesville, Florida, 32608-1197, United States
Miami VA Medical Center
Miami, Florida, 33125, United States
Study Chairperson
Miami, Florida, 33125, United States
Chicago VA Medical Center (West Side)
Chicago, Illinois, 60612, United States
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141, United States
New Orleans VAMC
New Orleans, Louisiana, 70112, United States
Boston VA Medical Center
Boston, Massachusetts, 02130, United States
Bronx VA Medical Center
The Bronx, New York, 10468, United States
Study Chairman
The Bronx, New York, 10468, United States
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104, United States
Vamc - Pittsburgh, Pittsburgh, Pa
Pittsburgh, Pennsylvania, 15240-1001, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
December 29, 2000
First Posted
January 4, 2001
Study Start
January 1, 1998
Study Completion
March 1, 2003
Last Updated
October 30, 2023
Record last verified: 2023-10