Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

Upsher-Smith Laboratories

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: USL255

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191086

P09-005

Details and patient eligibility

About

The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Enrollment: 210 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Open-label USL255

Experimental group

Description:

Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

Treatment:

Drug: USL255