An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy; Generalized Tonic-clonic Seizures

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01398956

N01361

Details and patient eligibility

About

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.

Enrollment: 44 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
• The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

Exclusion criteria

• Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Levetiracetam

Experimental group

Description:

Twice daily (morning and evening) orally

Treatment:

Drug: Levetiracetam