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

Epilepsy, Partial Clinical Trial

Official title:

A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160628
• Other study ID #: N01099
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: November 25, 2013
• Start date: March 2004
• Est. completion date: October 2004

Study information

• Verified date: February 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Partial

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (1)

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 pat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
Secondary	To assess safety of levetiracetam

External Links

•   Clinical Study Summary on UCB.com