Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
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ClinicalTrials.gov Identifier: NCT01142193 |
Recruitment Status :
Completed
First Posted : June 11, 2010
Results First Posted : May 7, 2014
Last Update Posted : May 22, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy | Drug: USL255 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 249 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: USL255 |
Drug: USL255 |
Placebo Comparator: Placebo |
Drug: Placebo |
- Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. [ Time Frame: 11 weeks ]
- 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. [ Time Frame: 11 weeks ]
- Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. [ Time Frame: 3 weeks (weeks 1-3) ]
- Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. [ Time Frame: 3 weeks (weeks 1-3) ]
- Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase. [ Time Frame: 11 weeks ]
- Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline. [ Time Frame: 3 weeks (weeks 1-3) ]
- 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. [ Time Frame: 11 weeks ]
- Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. [ Time Frame: 8 weeks (weeks 4-11) ]
- Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. [ Time Frame: 8 weeks (weeks 4-11) ]
- Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. [ Time Frame: 8 weeks (weeks 4-11) ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142193

Responsible Party: | Upsher-Smith Laboratories |
ClinicalTrials.gov Identifier: | NCT01142193 |
Other Study ID Numbers: |
P09-004 2009-016996-31 ( EudraCT Number ) |
First Posted: | June 11, 2010 Key Record Dates |
Results First Posted: | May 7, 2014 |
Last Update Posted: | May 22, 2014 |
Last Verified: | May 2014 |
Epilepsy partial onset seizure adjunctive therapy |
Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Neurologic Manifestations Topiramate Anticonvulsants Hypoglycemic Agents Physiological Effects of Drugs |