Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00518713 · ClinicalTrials.gov registry record · Phase 3
Clobazam in Patients With Lennox-Gastaut Syndrome
A Phase 3 study of Epilepsy and Seizures, sponsored by Lundbeck.
- Completed
- Registry status
- Phase 3
- Development phase
- 238
- Enrollment target
- 20
- Study locations
NCT00518713 is a Phase 3 study of Epilepsy and Seizures that has completed, run by Lundbeck. The registered enrollment target is 238 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT00518713, a Phase 3 study of Epilepsy and Seizures, has completed, sponsored by Lundbeck.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 238 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (75% lower). The listed sponsor is Lundbeck, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT00518713 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, Illinois, Arizona.
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.
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).
Who is sponsoring clinical trial NCT00518713?
This trial is sponsored by Lundbeck, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Epilepsy
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.
-
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
RECRUITING · Phase 3
-
Lemborexant Treatment of Insomnia Linked to Epilepsy
RECRUITING · Phase 3
-
RNS System NAUTILUS Study
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
COMPLETED · Phase 3
-
Pediatric Epilepsy Study
COMPLETED · Phase 3
-
IV Lacosamide: The Safety of Intravenous Lacosamide
COMPLETED · Phase 3
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.