Open Label Safety and Efficacy Study of Levetiracetam in... | NCT00160628

Studies
Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy

NCT00160628

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Nov 26, 2013Estimated

Enrollment

100

Phase

Phase 3

Conditions

Epilepsy, Partial

Interventions

Levetiracetam

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Oct 2004Actual

Completion Date

Oct 2004Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2013

Last Update Posted Date

Nov 26, 2013Estimated

Description Module

Brief Summary

A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Levetiracetam	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).

Secondary Outcomes

Measure	Description	Time Frame
To assess safety of levetiracetam

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion Criteria:

Subjects on felbamate with less than 18 months exposure.
Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
Presence of known pseudoseizures within the last year.
Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
UCB Clinical Trial Call Center	UCB Pharma	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17369059	Result	Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F. Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure. 2007 Jul;16(5):402-9. doi: 10.1016/j.seizure.2007.02.011. Epub 2007 Mar 19.

ID	Term
D004828	Epilepsies, Partial
D004827	Epilepsy

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144