Open-label Extension Study to Evaluate the Safety 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:
NCT01191086
First received: August 26, 2010
Last updated: February 9, 2015
Last verified: February 2015
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
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 [ Time Frame: Open label treatment of up to 62 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 210
Study Start Date: October 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label USL255
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Drug: USL255
Other Name: Topiramate extended-release

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: February 9, 2015
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 26, 2015