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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:
ClinicalTrials.gov Identifier:
NCT01191086
First Posted: August 30, 2010
Last Update Posted: February 23, 2015
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.
Information provided by (Responsible Party):
Upsher-Smith Laboratories
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01191086


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

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01191086     History of Changes
Other Study ID Numbers: P09-005
First Submitted: August 26, 2010
First Posted: August 30, 2010
Results First Submitted: February 9, 2015
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents