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Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

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UCB

Status and phase

Completed
Phase 3

Conditions

Epilepsy

Treatments

Drug: Carbamazepine Controlled Release (CBZ-CR)
Drug: Levetiracetam
Drug: Valproate Extended Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00175903
2004-001339-41 (EudraCT Number)
N01175

Details and patient eligibility

About

Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

Enrollment

1,701 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of epilepsy (all types of seizures) was made during the past year
  • Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
  • Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion criteria

  • Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
  • Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
  • Pregnant or lactating women
  • Presence of known pseudoseizures within the last year
  • Uncountable seizures (clusters) or history of convulsive status epilepticus
  • Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
  • History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
  • Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
  • Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,701 participants in 2 patient groups

Levetiracetam
Experimental group
Description:
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Treatment:
Drug: Levetiracetam
Older Antepileptic Drugs
Active Comparator group
Description:
Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
Treatment:
Drug: Carbamazepine Controlled Release (CBZ-CR)
Drug: Valproate Extended Release

Trial contacts and locations

231

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Data sourced from clinicaltrials.gov

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