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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191086
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Information provided by (Responsible Party):
Upsher-Smith Laboratories

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: USL255 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Topiramate

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191086

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United States, Arizona
Phoenix, Arizona, United States
United States, California
Ventura, California, United States
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Gainsville, Florida, United States
Gulf Breeze, Florida, United States
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Sponsors and Collaborators
Upsher-Smith Laboratories

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Upsher-Smith Laboratories Identifier: NCT01191086     History of Changes
Other Study ID Numbers: P09-005
First Posted: August 30, 2010    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 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