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Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 9, 2010
First Posted Date  ICMJE June 11, 2010
Results First Submitted Date  ICMJE April 3, 2014
Results First Posted Date  ICMJE May 7, 2014
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
  • 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.
  • Proportions of subjects with ≥50% reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.
  • Percent reductions from baseline in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.
  • Percent reduction from baseline in weekly (7 day) all seizure frequency during the titration plus maintenance phase.
  • Proportions of subjects with ≥25%, ≥75%, and 100% reduction in weekly (7 day) partial-onset seizure frequency during the titration, maintenance and titration plus maintenance phases, separately.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: USL255
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: USL255
    Intervention: Drug: USL255
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2014)
249
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2010)
216
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Chile,   Germany,   Greece,   Hungary,   India,   Israel,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01142193
Other Study ID Numbers  ICMJE P09-004
2009-016996-31 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Upsher-Smith Laboratories
Study Sponsor  ICMJE Upsher-Smith Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Upsher-Smith Laboratories
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP