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NCT01318408 · ClinicalTrials.gov registry record · Phase 4
Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia
A Phase 4 study of Epilepsy, sponsored by Drexel University College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01318408: Completed Phase 4 study of Epilepsy, sponsored by Drexel University College of Medicine.
NCT01318408 is a Phase 4 study of Epilepsy that has completed, run by Drexel University College of Medicine. The registered enrollment target is 24 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01318408, a Phase 4 study of Epilepsy, has completed, sponsored by Drexel University College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The MMSE (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of Food and Drug Administration (FDA) products approved for the treatment of AD. The MMSE consists of five components; 1) orientation to time and place, 2) registration of three words, 3) attention and calculation, 4) recall of three words, and 5) language. The scores from each of the five components are summed to obtain the overall MMSE score. The scor
Conditions Studied
Interventions
- DRUG Levetiracetam
Study Locations (1)
Pennsylvania
- Drexel University College of Medicine, Dept of Neurology - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 4 |
What the finished NCT01318408 record still lists
NCT01318408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Levetiracetam is the first listed.
NCT01318408 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01318408 about?
NCT01318408 is a clinical study titled "Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia". 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 grou...
What is the current status of trial NCT01318408?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2006-11. Estimated completion is 2008-03.
What conditions does trial NCT01318408 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT01318408?
The interventions under investigation include: Levetiracetam (DRUG).
Who is sponsoring clinical trial NCT01318408?
This trial is sponsored by Drexel University College of Medicine, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01318408 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01318408's enrollment target sits among peer trials
24 123rd of 160 higher than 32 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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