Phase 3
N=249
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01142193 ↗Enrolled (actual)
249
Serious AEs
1.6%
Results posted
May 2014
Primary outcome: Primary: Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. — 39.5; 21.65 Percent Reduction — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- USL255 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Upsher-Smith Laboratories
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. |
39.5; 21.65 | <.001 sig |
| SECONDARY Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. |
37.9; 23.2 | 0.013 sig |
| SECONDARY Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. |
33.9; 17.6 | 0.007 sig |
| SECONDARY Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. |
33.93; 8.57 | <0.001 sig |
| SECONDARY Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase. |
39.50; 21.65 | <0.001 sig |
| SECONDARY Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline. |
56.5; 34.4; 16.9; 7.2; 12.1; 3.2 | — |
| SECONDARY Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. |
66.9; 46.4; 15.3; 4.8; 3.2; 1.6 | — |
| SECONDARY Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. |
72.6; 46.7; 26.5; 9.2; 7.1; 3.3 | — |
| SECONDARY Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. |
45.70; 22.09 | 0.001 sig |
| SECONDARY Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. |
44.2; 30.8 | 0.048 sig |
Summary
The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Eligibility Criteria
Inclusion Criteria
- Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
- Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
- Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.
Exclusion Criteria
- Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
- Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
- Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
- Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
- Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
- Have taken topiramate within the past 6 months.
Data sourced from ClinicalTrials.gov (NCT01142193). 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.