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Completed

NCT Number: NCT00175903

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.

Carbamazepine Controlled Release (CBZ-CR)

Drug

Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.

Valproate Extended Release

Drug

Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.

Primary outcomes

  1. Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety

    Time frame: Visit 1 to End of Study (approximately 52 weeks)

Secondary outcomes

  1. The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release

    Time frame: Visit 1 to End of Study (approximately 52 weeks)

  2. The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs

    Time frame: Visit 1 to Visit 4 (approximately 26 weeks)

  3. The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs

    Time frame: Visit 1 to Visit 5 (approximately 52 weeks)

  4. The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release

    Time frame: Visit 1 to Visit 4 (approximately 26 weeks)

  5. The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release

    Time frame: Visit 1 to Visit 5 (approximately 52 weeks)

  6. Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs

    Time frame: Visit 1 to Visit 4 (approximately 26 weeks)

  7. Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs

    Time frame: Visit 1 to Visit 5 (approximately 52 weeks)

  8. Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release

    Time frame: Visit 1 to Visit 4 (approximately 26 weeks)

  9. Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release

    Time frame: Visit 1 to Visit 5 (approximately 52 weeks)

  10. Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs

    Time frame: Visit 1 to End of Study (approximately 52 weeks)

  11. Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release

    Time frame: Visit 1 to End of Study (approximately 52 weeks)

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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