Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01191086
First received: August 26, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: USL255
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study

Resource links provided by NLM:


Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Evaluate the safety of USL255 through the collection of adverse events and clinical laboratory evaluations

Secondary Outcome Measures:
  • Summary of weekly seizure frequency during the open-label treatment study.

Estimated Enrollment: 172
Study Start Date: October 2010
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL255 Open Label Study Drug: USL255

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed the maintenance period of the P09-004 study.
  • Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191086

  Show 68 Study Locations
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01191086     History of Changes
Other Study ID Numbers: P09-005
Study First Received: August 26, 2010
Last Updated: February 22, 2013
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