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Clobazam in Patients With Lennox-Gastaut Syndrome
NCT00518713 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Clobazam Low Dose
- DRUG Clobazam Medium Dose
- DRUG Clobazam High Dose
Study Locations (20)
Florida
- Pediatric Neurology and Epilepsy Center — Loxahatchee Groves
- Child Neurology Center of NW FL — Pensacola
- University of South Florida — Tampa
- Pediatric Epilepsy & Neurology Specialists — Tampa
Illinois
- Rush University Medical Center — Chicago
- University of Chicago Medical Center — Chicago
- Children's Memorial Hospital — Chicago
Arizona
- St. Joseph's Hospital and Medical Center — Phoenix
- Phoenix Children's Hospital — Phoenix
Alabama
- University of Alabama at Birmingham — Huntsville
California
- Childrens Hospital Los Angeles — Los Angeles
Colorado
- The Children's Hospital — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Georgia
- Medical College of Georgia — Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2007-08 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00518713
The ClinicalTrials.gov registry entry for NCT00518713 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 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lundbeck, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Epilepsy appearing as the primary indexed condition, and to 4 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: NCT00518713 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, Illinois, Arizona. 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 NCT00518713 about?
NCT00518713 is a clinical study titled "Clobazam in Patients With Lennox-Gastaut Syndrome". The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U...
What is the current status of trial NCT00518713?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2007-08. Estimated completion is 2010-04.
What conditions does trial NCT00518713 study?
This clinical trial studies the following conditions: Epilepsy, Seizures, Epilepsy, Generalized. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00518713?
The interventions under investigation include: Placebo (DRUG), Clobazam Low Dose (DRUG), Clobazam Medium Dose (DRUG), Clobazam High Dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00518713?
This trial is sponsored by Lundbeck, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00518713 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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