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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
  Purpose

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 Intervention Phase
Epilepsy
Drug: USL255
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.

Secondary Outcome Measures:
  • 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.

Enrollment: 249
Study Start Date: May 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL255 Drug: USL255
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142193

  Show 69 Study Locations
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01142193     History of Changes
Other Study ID Numbers: P09-004, 2009-016996-31
Study First Received: June 9, 2010
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
Epilepsy
partial onset seizure
adjunctive therapy

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014