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

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

EU CTR

Registry ID

EUCTR2009-017904-95-BE

Enrollment

275

Registered

2010-04-13

Start date

2010-06-28

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Refractory partial-onset seizures with or without secondary generalization MedDRA version: 14.0 Level: PT Classification code 10056209 Term: Partial seizures with secondary generalisation System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0 Level: LLT Classification code 10034090 Term: Partial seizures, complex System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0 Level: PT Classification code 10040703 Term: Simple partial seizures System Organ C

Interventions

Product Name: Topiramate extended-release Product Code: USL255 Pharmaceutical Form: Capsule INN or Proposed INN: Topiramate CAS Number: 97240-79-4 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: n/a

Design outcomes

Primary

Measure	Time frame
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):	—

Measure

Time frame

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):

—

Countries

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

Contacts

Public ContactClinical Development

Upsher-Smith Laboratories, Inc.

mark.halvorsen@upsher-smith.com+1763315-2000

Outcome results

None listed

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