Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

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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)

66 participants in 1 patient group

Levetiracetam
Experimental group
Description:
Subjects received open-label Levetiracetam.
Treatment:
Drug: Levetiracetam

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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