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Trial record 1 of 1 for:    NCT01191086
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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: May 15, 2014
Last verified: May 2014

August 26, 2010
May 15, 2014
October 2010
May 2014   (final data collection date for primary outcome measure)
Evaluate the safety of USL255 through the collection of adverse events and clinical laboratory evaluations
Same as current
Complete list of historical versions of study NCT01191086 on ClinicalTrials.gov Archive Site
Summary of weekly seizure frequency during the open-label treatment study.
Same as current
Not Provided
Not Provided
 
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
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

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

Not Provided
Interventional
Phase 3
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: USL255
Experimental: USL255 Open Label Study
Intervention: Drug: USL255
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
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,   India,   Israel,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain
 
NCT01191086
P09-005
Not Provided
Upsher-Smith Laboratories
Upsher-Smith Laboratories
Not Provided
Not Provided
Upsher-Smith Laboratories
May 2014

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