Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures who had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo–Controlled, Parallel-Group, Phase 3 Study

• Conditions: Refractory partial-onset seizures with or without secondary generalization; MedDRA version: 14.0Level: LLTClassification code 10034090Term: Partial seizures, complexSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0Level: PTClassification code 10056209Term: Partial seizures with secondary generalisationSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0Level: PTClassification code 10040703Term: Simple partial seizuresSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0Level: LLTClassification code 10048674Term: Partial seizures with secondary generalizationSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0Level: LLTClassification code 10034091Term: Partial seizures, simpleSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0Level: PTClassification code 10010145Term: Complex partial seizuresSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-017904-95-GR
• Lead Sponsor: psher-Smith Laboratories, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-20
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Have completed the maintenance period of the P09-004 study, unless otherwise approved by the sponsor.
• Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

n/a

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the safety and tolerability of USL255 (up to 400mg/day) given as adjunctive treatment in subjects with refractory partial-onset seizures with or without secondary generalization.;Secondary Objective: The secondary objective is to assess seizure frequency in subjects with refractory partial-onset seizures with or without secondary generalization receiving open-label USL255.;Primary end point(s):