Status:

COMPLETED

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

Lead Sponsor:

UCB Pharma

Conditions:

Epilepsy, Partial

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures. The optimal dose in daily clinical practice will be used.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 24 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 12 2006

Estimated Enrollment :

251 Patients enrolled

Trial Details

Trial ID

NCT00160654

Start Date

November 24 2003

End Date

December 12 2006

Last Update

August 19 2020

Active Locations (29)

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Page 1 of 8 (29 locations)

1

N01036 808

Hong Kong, Hong Kong

2

N01036 842

Hong Kong, Hong Kong

3

N01036 815

Kwun Tong, Hong Kong

4

N01036 811

Kuala Lumpur, Malaysia