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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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ClinicalTrials.gov Identifier: NCT00175903
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date March 17, 2015
Study Start Date  ICMJE February 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
TIME TO WITHDRAWAL OF STUDY MEDICATION AS A COMBINED MEASURE OF EFFICACY AND SAFETY
Change History Complete list of historical versions of study NCT00175903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • 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) ]
  • The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
  • The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
  • 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) ]
  • 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) ]
  • Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
  • Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
  • 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) ]
  • 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) ]
  • Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • EFFICACY:
  • - RETENTION RATE
  • - SEIZURE FREEDOM AT 6 AND 12 MONTHS.
  • - TIME TO FIRST SEIZURE.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Levetiracetam
    Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
  • Drug: Carbamazepine Controlled Release (CBZ-CR)
    Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
  • Drug: Valproate Extended Release
    Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Study Arms  ICMJE
  • Experimental: Levetiracetam
    Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
    Intervention: Drug: Levetiracetam
  • Active Comparator: Older Antepileptic Drugs
    Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
    Interventions:
    • Drug: Carbamazepine Controlled Release (CBZ-CR)
    • Drug: Valproate Extended Release
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2008)
1701
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
2000
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Netherlands,   Norway,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries Portugal
 
Administrative Information
NCT Number  ICMJE NCT00175903
Other Study ID Numbers  ICMJE N01175
2004-001339-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center UCB Pharma
PRS Account UCB Pharma
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP