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

Epilepsy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175903
• Other study ID #: N01175
• Secondary ID: 2004-001339-41
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 12, 2015
• Start date: February 2005
• Est. completion date: October 2007

Study information

• Verified date: March 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesIreland: Irish Medicines BoardItaly: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSpain: Ministry of Health and ConsumptionSweden: Medical Products AgencySwitzerland: SwissmedicTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute of PharmacyRomania: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1701
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
• Carbamazepine Controlled Release (CBZ-CR)
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
• Valproate Extended Release
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety		Visit 1 to End of Study (approximately 52 weeks)	No
Secondary	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		Visit 1 to End of Study (approximately 52 weeks)	No
Secondary	The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs		Visit 1 to Visit 4 (approximately 26 weeks)	No
Secondary	The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs		Visit 1 to Visit 5 (approximately 52 weeks)	No
Secondary	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		Visit 1 to Visit 4 (approximately 26 weeks)	No
Secondary	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		Visit 1 to Visit 5 (approximately 52 weeks)	No
Secondary	Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs		Visit 1 to Visit 4 (approximately 26 weeks)	No
Secondary	Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs		Visit 1 to Visit 5 (approximately 52 weeks)	No
Secondary	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		Visit 1 to Visit 4 (approximately 26 weeks)	No
Secondary	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		Visit 1 to Visit 5 (approximately 52 weeks)	No
Secondary	Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs		Visit 1 to End of Study (approximately 52 weeks)	No
Secondary	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		Visit 1 to End of Study (approximately 52 weeks)	No

External Links

•   Clinical Study Summary on UCB.com