Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

Study Overview

• Status: Completed
• Conditions: Epilepsy, Partial
• Intervention / Treatment: Drug: Levetiracetam

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
• Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion Criteria:

• Patients who had not participate in N165 Clinical Trial of L059.
• Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
• Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levetiracetam; Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).	Drug: Levetiracetam; Pharmaceutical form: Film-coating tablets; Concentration: 250 mg/ 500 mg; Route of administration: oral use; Other Names: Keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial (Type I) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.	From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.	From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.	From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.	From Baseline up to 54 months

Collaborators and Investigators

• Sponsor: UCB Japan Co. Ltd.

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2001
• Primary Completion (Actual): January 17, 2007
• Study Completion (Actual): January 17, 2007

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Levetiracetam; Keppra; Epilepsy, partial
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No