At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Phase 4, Open-Label, Twelve-Week Study to Examine the Cognitive Impact and Tolerability of Levetiracetam (Keppra) in Elderly Patients With Seizures of Partial Onset
In Brief
A Phase 4 clinical trial evaluating Levetiracetam for Epilepsy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
Elderly persons with dementia are at risk for seizures, however, traditional anticonvulsants are poorly tolerated in this population. Our goal is to examine Levetiracetam (Keppra) in elderly dementia patients with seizures. While it has been established that Keppra controls seizures in this age group, it is important to demonstrate that treatment with Keppra would not affect cognitive abilities in this large population of patients . As this population is already cognitively impaired, the best choice of anticonvulsant would be one that does not further compromise their cognitive abilities. Keppra is an excellent anticonvulsant agent in the elderly for a variety of reasons, including safety, favorable side effect profile, lack of interaction with other drugs, and efficacy. Our retrospective pilot data suggests that cognition is not negatively affected by Keppra. The current prospective study will assess the cognitive abilities of persons with cognitive impairment at baseline and at weeks 4 and 12. The overall objective is to determine the cognitive tolerability of Keppra for seizures in elderly cognitively impaired patients.
Study Details
Timeline
Interventions
Titration of Keppra will start at 250 mg by mouth twice daily for three days. Then 500 mg by mouth twice daily for three days. Then 750 mg by mouth twice daily for the duration of the study, or for as long as treatment is necessary. This titration schedule is subject to change based on subject's tolerability.