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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01142193
First received: June 9, 2010
Last updated: February 5, 2014
Last verified: February 2014

June 9, 2010
February 5, 2014
May 2010
December 2012   (final data collection date for primary outcome measure)
Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.
Same as current
Complete list of historical versions of study NCT01142193 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
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

The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Epilepsy
  • Drug: USL255
  • Drug: Placebo
  • Experimental: USL255
    Intervention: Drug: USL255
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
January 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   Chile,   Germany,   Greece,   Hungary,   India,   Israel,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain
 
NCT01142193
P09-004, 2009-016996-31
Not Provided
Upsher-Smith Laboratories
Upsher-Smith Laboratories
Not Provided
Not Provided
Upsher-Smith Laboratories
February 2014

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