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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.
Information provided by (Responsible Party):
Upsher-Smith Laboratories Identifier:
First received: August 26, 2010
Last updated: February 9, 2015
Last verified: February 2015
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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01191086

  Show 68 Study Locations
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

Responsible Party: Upsher-Smith Laboratories 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

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents processed this record on September 21, 2017