Phase 3 N=210 Treatment

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

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT01191086 ↗

Enrolled (actual)

210

Serious AEs

6.7%

Results posted

Feb 2015

Primary outcome: Primary: Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations — 210; 146; 102; 15 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: USL255 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Upsher-Smith Laboratories
Primary completion: May 2014

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	—

Summary

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

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.

View full record on ClinicalTrials.gov →

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.