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NCT00007670 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Seizures, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 720
- Enrollment target
- 20
- Study locations
NCT00007670 is a Phase 3 study of Seizures that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 720 participants, below the 916-participant average among 39 other Seizures trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT00007670, a Phase 3 study of Seizures, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 720 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Lamotrigine
- DRUG Gabapentin
- DRUG Carbamazepine
Study Locations (20)
Florida
- Vamc - Bay Pines, Fl - Bay Pines
- Gainesville VA Medical Center - Gainesville
- Miami VA Medical Center - Miami
- Study Chairperson - Miami
California
- Vamc - West Los Angeles, Los Angeles, Ca - Los Angeles
- Vamc - San Diego, San Diego, Ca - San Diego
- San Francisco VAMC - San Francisco
Illinois
- Chicago VA Medical Center (West Side) - Chicago
- Edward Hines Jr. VA Hospital - Hines
New York
- Bronx VA Medical Center - The Bronx
- Study Chairman - The Bronx
Alabama
- Birmingham VA Medical Center - Birmingham
Arizona
- Carl T. Hayden VA Medical Center - Phoenix
Colorado
- Denver VA Medical Center - Denver
Louisiana
- New Orleans VAMC - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 1998-01 |
| Est. Completion | 2003-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007670
The ClinicalTrials.gov registry entry for NCT00007670 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 916-participant average among 39 other Seizures trials with a reported enrollment target (21% lower). The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 3 interventions - of which Lamotrigine is the first listed.
NCT00007670 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00007670 about?
NCT00007670 is a clinical study titled "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.". 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 r...
What is the current status of trial NCT00007670?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 720 participants. The study started on 1998-01. Estimated completion is 2003-03.
What conditions does trial NCT00007670 study?
This clinical trial studies the following conditions: Seizures.
What interventions are being tested in trial NCT00007670?
The interventions under investigation include: Lamotrigine (DRUG), Gabapentin (DRUG), Carbamazepine (DRUG).
Who is sponsoring clinical trial NCT00007670?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00007670 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.