Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

Generalized Epilepsy Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-clonic Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150735
• Other study ID #: N01061
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: November 25, 2013
• Start date: June 2002
• Est. completion date: July 2005

Study information

• Verified date: July 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlSweden: Medical Products AgencyNetherlands: Medicines Evaluation Board (MEB)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFinland: Finnish Medicines AgencySouth Africa: Medicines Control CouncilFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Subjects with newly or recently diagnosed epilepsy having experienced 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. The discrimination between IC and IIE is not requested for inclusion.

• Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.

• Subjects with a confirmed diagnosis of epilepsy.

• Male/female subjects (=16 years).

Exclusion Criteria:

• History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.

• History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. < 20 minutes, with or without function regained between 2 ictal events.

• History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Generalized Epilepsy

Intervention

Drug:
• LEVETIRACETAM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (1)

Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ; Levetiracetam Monotherapy Study Group. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology. 2007 Feb 6;68(6):402-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.
Secondary	Proportion of subjects with one year seizure freedom; time to first seizure; safety.

External Links

•   Clinical Study Summary on UCB.com