Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures (a type of epilepsy of fits) who had participated in study P09-004.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/06/002721

Enrollment

172

Registered

2012-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Refractory Partial-Onset Seizures

Interventions

Intervention1: Experimental: USL255 Open Label Study: Drug: USL255 (Between 50mg QD and upto 200mg QD) (52 Weeks) Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1. Have completed the maintenance period of the P09-004 study. 2. Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Evaluate the safety of USL255 through the collection of adverse events and clinical laboratory evaluations.Timepoint: As per study protocol	—

Secondary

Measure	Time frame
Summary of weekly seizure frequency during the open-label treatment study.Timepoint: Weekly	—

Countries

Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, Hungary, India, Israel, New Zealand, Poland, Russian Federation, South Africa, Spain, United States of America

Contacts

Public ContactArun Sundriyal

PPD Pharmaceutical Development India Pvt. Ltd.

Arun.Sundriyal@ppdi.com911244739903

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026