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Home > "D" Clinical Trials Conditions > 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.  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.
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.
For Condition: seizures in the elderly
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Parke-Davis,Glaxo Wellcome
Synopsis: 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.
Details: Primary Hypothesis: The primary hypothesis for this study is that one or both of two newly FDA approved antiepileptic drugs, gabapentin and lamotrigine, will have significantly fewer side-effects while providing equal or possibly better seizure control than the current world-wide drug of choice, carbamazepine, for the treatment of seizures in the elderly. Secondary Hypotheses: Secondary aims of the study are to determine which of the three drugs being studied (1) has the fewest side-effects, (2) produces the best seizure control, (3) has the least impairment of cognitive function, (4) has the best effect on mood and (5) has the best effect on quality of life. Intervention: Patients are randomized to carbamazepine, gabapentin or lamotrigine. Target doses are 600mg for carbamazepine (200mg tablets overencapsulated), 1500mg for gabapentin (300mg capsules), and 150mg for lamotrigine (25mg tablets). Carbamazepine and gabapentin patients also receive a placebo tablet while lamotrigine patients also receive a placebo capsule. Primary Outcomes: The primary outcome measure is retention in the study at 12 months. Major secondary outcomes are seizure frequency during first 12 months, time to first seizure, total scores from Systemic Toxicity and Neurotoxicity Rating Scales, the Mattis Dementia Rating Scale (cognitive function), Hamilton Depression Scale (mood) and SF-36 Health Survey (quality of life). Study Abstract: 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. Thus, the primary objective of this study is to evaluate the tolerability and efficacy of these two new antiepileptic drugs individually compared to a standard antiepileptic drug, carbamazepine, in an elderly population (>60 years of age) with new onset, unprovoked epileptic seizures. The study is a 63-month, randomized, double-blind trial of three antiepileptic drugs: carbamazepine, gabapentin, and lamotrigine. Patient recruitment occured during the first 51 months with each patient being followed for at least one year. There were 594 patients enrolled from 18 VA medical centers. Patients are veterans 60 years of age or older who have new onset, unprovoked seizures of focal onset, with or without secondary generalization. Patients with seizures secondary to toxic-metabolic causes, acute medical or neurological conditions or progressive diseases of the brain such as brain tumors are excluded. A double-dummy design is being employed to preserve the blind. Target doses for the study medications are: carbamazepine-600 mg., gabapentin-1500 mg., and lamotrigine-150 mg. Patients are assessed biweekly during the first 8 weeks, every 4 weeks until week 24 and every 8 weeks until week 52. Patients wishing to continue on their study drug after 52 weeks are seen quarterly for an additional year.
Eligibility:
Study Type: Interventional, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: Veterans 60 years of age or older who have new onset, unprovoked seizures of focal onset, with or without secondary generalization.
Total Enrollment: 720
Location and Contact Information:
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
United States
San Francisco VAMC
San Francisco, California, 94121
United States
Vamc - Pittsburgh, Pittsburgh, Pa
Pittsburgh, Pennsylvania, 15240-1001
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
Miami VA Medical Center
Miami, Florida, 33125
United States
Dallas VA Medical Center
Dallas, Texas, 75216
United States
Denver VA Medical Center
Denver, Colorado, 80220
United States
Gainesville VA Medical Center
Gainesville, Florida, 32608-1197
United States
Study Chairperson
Miami, Florida, 33125
United States
Chicago VA Medical Center (West Side)
Chicago, Illinois, 60612
United States
Study Chairman
Bronx, New York, 10468
United States
New Orleans VAMC
New Orleans, Louisiana, 70112
United States
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141
United States
Vamc - San Diego, San Diego, Ca
San Diego, California, 92161
United States
Vamc - Bay Pines, Fl
Bay Pines, Florida, 33744
United States
Bronx VA Medical Center
Bronx, New York, 10468
United States
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
United States
Birmingham VA Medical Center
Birmingham, Alabama, 35233
United States
Boston VA Medical Center
Boston, Massachusetts, 02130
United States
Additional Information:
Study ID Numbers: 428;
Study Start Date: January 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007670
Other Seizures In The Elderly Studies:
1. 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.
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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.
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