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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 26, 2010
Last Updated Date	February 22, 2013
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 27, 2010)	Evaluate the safety of USL255 through the collection of adverse events and clinical laboratory evaluations
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01191086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 27, 2010)	Summary of weekly seizure frequency during the open-label treatment study.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Official Title ^ICMJE	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
Brief Summary	The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Epilepsy
Intervention ^ICMJE	Drug: USL255
Study Arm (s)	Experimental: USL255 Open Label Study Intervention: Drug: USL255
Publications *	Not Provided
* 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	Active, not recruiting
Estimated Enrollment ^ICMJE	172
Completion Date	Not Provided
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, India, Israel, New Zealand, Poland, Russian Federation, South Africa, Spain

Administrative Information
NCT Number ^ICMJE	NCT01191086
Other Study ID Numbers ^ICMJE	P09-005
Has Data Monitoring Committee	Not Provided
Responsible Party	Upsher-Smith Laboratories
Study Sponsor ^ICMJE	Upsher-Smith Laboratories
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Upsher-Smith Laboratories
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top