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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191086
• Other study ID #: P09-005
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2010
• Last updated: February 9, 2015
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Upsher-Smith Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• USL255

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Upsher-Smith Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  Germany,  Greece,  India,  Israel,  New Zealand,  Poland,  Russian Federation,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations		Open label treatment of up to 62 weeks	Yes