Follow on study for participants involved in the P09- 004 Study which examines if USL255 is safe in patients with refractory partial-onset seizures

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 275

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 227
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

n/a

Study & Design

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