Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Tonic-clonic

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150813

N01127

Details and patient eligibility

About

An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Enrollment: 66 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a confirmed diagnosis of epilepsy.
• Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
• Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]).
• Male/female subjects (>= 16 years).

Exclusion criteria

• Need for an additional Antiepileptic Drug (AED).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Levetiracetam

Experimental group

Description:

Subjects received open-label Levetiracetam.

Treatment:

Drug: Levetiracetam