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

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UCB

Status and phase

Completed
Phase 4

Conditions

Epilepsy, Partial

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

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

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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