Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

UCB

Status and phase: Completed; Phase 4

Conditions: Epilepsy, Partial

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160654

N01036

Details and patient eligibility

About

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
• Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
• Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.

Exclusion criteria

• Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
• Presence of known pseudoseizures within the last year.
• Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
• Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

251 participants in 1 patient group

Levetiracetam

Experimental group

Description:

Subjects received open-label Levetiracetam.

Treatment:

Drug: Levetiracetam