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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
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: USL255 Drug: Placebo Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Topiramate

Arms and Interventions
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Arm Intervention/treatment
Experimental: USL255 Drug: USL255
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]
  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) ]
  4. Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase. [ Time Frame: 11 weeks ]
  5. 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) ]
  6. 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 ]
  7. 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) ]
  8. 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) ]
  9. 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) ]

Eligibility Criteria
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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Upsher-Smith Laboratories
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Upsher-Smith Laboratories:
Epilepsy
partial onset seizure
adjunctive therapy
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurologic Manifestations
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs