A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

UCB

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Epilepsies, Partial

Treatments: Drug: Seletracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422110

N01272

Details and patient eligibility

About

This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects from 16 to 70 years old
• Confirmed diagnosis of focal epilepsy
• Partial seizures uncontrolled while taking 1 or 2 AEDs
• At least 8 partial seizures during the 8-week baseline period

Exclusion criteria

• Seizures occurring only in clusters
• Status epilepticus within 1 year
• Progressive CNS disorder
• Other serious or uncontrolled diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind