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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01191086
• Date of registration: 26/08/2010
• Prospective Registration: Yes
• Primary sponsor: Upsher-Smith Laboratories
• Public title: Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
• Scientific 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
• Date of first enrolment: October 2010
• Target sample size: 210
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01191086
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

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

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: USL255

Primary Outcome(s)

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]

Secondary ID(s)

P09-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/02/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01191086