NCT00150748

Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 4 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

Conditions

• Generalized Epilepsy

Interventions

Type	Name	Description
DRUG	Levetiracetam 166 mg	* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 166 mg * Route of Administration: Oral use
DRUG	Levetiracetam 250 mg	* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 250 mg * Route of Administration: Oral use
DRUG	Levetiracetam 500 mg	* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 500 mg * Route of Administration: Oral use

Timeline

• Start date: 2001-11-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-09-08
• Last updated: 2020-07-29