Phase 3
Completed N=210
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Source: ClinicalTrials.gov NCT01191086 ↗Enrolled (actual)
210
Serious AEs
6.7%
Results posted
Feb 2015
Primary outcomePrimary: Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations — 210; 146; 102; 15 participants
Summary
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations |
210; 146; 102; 15; 14; 20 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01191086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.