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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Partial

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160615

N01020

Details and patient eligibility

About

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

Enrollment: 154 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

Levetiracetam

Experimental group

Description:

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).

Treatment:

Drug: Levetiracetam