Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

Epilepsy Clinical Trial

Official title:

Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600509
• Other study ID #: N165
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2008
• Last updated: September 16, 2013
• Start date: January 2001
• Est. completion date: July 2003

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• simple and/or complex partial seizures with or without secondary generalization, and first partial seizure >= 2 years before selection visit;

• seizures classifiable according to the ILAE classification;

• minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;

• exposed to two or more standard AEDs;

• taking up to three of the standard AEDs, at the initiation of the trial.

Exclusion Criteria:

• medication influencing the CNS, except for medication taken for antiepileptic treatment;

• partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;

• history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;

• presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma	UCB Japan Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	partial onset seizure frequency per week		collection of seizure count throughout the whole study (baseline and treatment periods)
Secondary	safety and tolerability		safety and tolerability data were collected throughout the study period

External Links

•   Clinical Study Summary on UCB.com