Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518713
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2007-08-20
Brief Title:
Clobazam in Patients With Lennox-Gastaut Syndrome
Sponsor:
Lundbeck LLC
Organization:
Lundbeck LLC
Study Overview
Official Title:
Double-Blind Placebo-Controlled Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 US 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
Detailed Description:
LGS poses a significant treatment challenge No single antiepileptic drug AED provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required Even with combination therapy many LGS patients show resistance to treatment Adjunctive therapy with newer anticonvulsant medications has demonstrated efficacy for some patients although polytherapy and high medication doses are often associated with unfavorable adverse event profiles
More effective and better-tolerated treatment options are needed for this population of medically intractable epilepsy patients Clobazam may provide an improved safety profile compared to other AEDs currently approved for the treatment of LGS and may have less hypotonia and drooling effects than other benzodiazepines
More effective and better-tolerated treatment options are needed for this population of medically intractable epilepsy patients Clobazam may provide an improved safety profile compared to other AEDs currently approved for the treatment of LGS and may have less hypotonia and drooling effects than other benzodiazepines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OV1012 | OTHER | Former study ID | None |