Epilepsy
Conditions
Keywords
Epilepsy, partial onset seizure, adjunctive therapy
Brief summary
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Interventions
DRUGUSL255
Sponsors
Upsher-Smith Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | Open label treatment of up to 62 weeks |
Countries
Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, India, Israel, New Zealand, Poland, Russia, South Africa, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-label USL255 Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255 | 210 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Discontinuation criterion met | 1 |
| Overall Study | Lack of Efficacy | 10 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 24 |
Baseline characteristics
| Characteristic | Open-label USL255 |
|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 11.09 |
| Sex: Female, Male Female | 114 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 61 / 210 |
| serious Total, serious adverse events | 14 / 210 |
Outcome results
Primary
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Time frame: Open label treatment of up to 62 weeks
Population: The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. of participants analyzed | 210 participants |
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. with ≥ 1 treatment-emergent AE | 146 participants |
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. with ≥ 1 treatment-related AE | 102 participants |
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. with severe AEs | 15 participants |
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. with serious AEs | 14 participants |
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. with TEAEs leading to study discontinuation | 20 participants |
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. of deaths related to study drug | 0 participants |
| Open-label USL255 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | No. of deaths unrelated to study drug | 1 participants |