Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

Epilepsy, Tonic-clonic Clinical Trial

Official title:

A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150787
• Other study ID #: N01093
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: November 25, 2013
• Start date: July 2003
• Est. completion date: November 2005

Study information

• Verified date: September 2009
• 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 ControlSpain: Ministry of Health and ConsumptionNetherlands: 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 HealthSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Subjects with a confirmed diagnosis of epilepsy.

• Subjects having experienced in the past 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

• Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion Criteria:

• Need for an additional AED.

Study Design

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Tonic-Clonic

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	Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs

External Links

•   Clinical Study Summary on UCB.com