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Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
NCT00334958 · View on ClinicalTrials.gov ↗
Study Summary
To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rufinamide
Study Locations (20)
Florida
- Bradenton Research Center — Bradenton
- University of Florida, Dept. of Neurology — Gainesville
- University of Florida, The Neuroscience Institute at Shands — Jacksonville
- Pediatric Neurologists of Palm Beach — Loxahatchee Groves
- Nemours Children's Clinic — Orlando
- Pediatric Neurology - PA — Orlando
- Bay Medical Center — Panama City
- University of Southern Florida, Dept. of Neurology — Tampa
Arizona
- Barrow Neurological Institute — Phoenix
- Mayo Clinic Epilepsy and Neurology — Phoenix
- University of Arizona, Dept. of Neurology — Tucson
California
- Neuro-Pain Medical Center, Inc. — Fresno
- Neurology Center — Oceanside
- California Pacific Epilepsy — San Francisco
Alabama
- University of South Alabama Medical Center — Mobile
- Neurology Clinic PC — Northport
District of Columbia
- Georgetown University Hospital, Dept. of Neurology — Washington D.C.
- Children's National Medical Center — Washington D.C.
Arkansas
- Clinical Trials, Inc — Little Rock
Georgia
- Child Neurology Associates, PC — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2006-02-13 |
| Est. Completion | 2009-05-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00334958
The ClinicalTrials.gov registry entry for NCT00334958 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 356 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00334958 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00334958 about?
NCT00334958 is a clinical study titled "Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures". To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
What is the current status of trial NCT00334958?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2006-02-13. Estimated completion is 2009-05-20.
What conditions does trial NCT00334958 study?
This clinical trial studies the following conditions: Epilepsy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00334958?
The interventions under investigation include: Placebo (DRUG), Rufinamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00334958?
This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00334958 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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