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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: Completed Phase 3 study of Epilepsy and Seizures, sponsored by Lundbeck.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
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 |
What the finished NCT00518713 record still lists
NCT00518713 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (75% lower).
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 names 20 study sites across 14 states, led by 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
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Where NCT00518713's enrollment target sits among peer trials
238 26th of 160 higher than 135 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.
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