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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.
Information provided by (Responsible Party):
Upsher-Smith Laboratories Identifier:
First received: August 26, 2010
Last updated: February 9, 2015
Last verified: February 2015
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: USL255

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Open-label USL255

Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day


Participant Flow:   Overall Study
    Open-label USL255
STARTED   210 
Adverse Event                20 
Lack of Efficacy                10 
Lost to Follow-up                4 
Physician Decision                2 
Withdrawal by Subject                24 
Discontinuation criterion met                1 
Other                1 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Open-label USL255

Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day


Baseline Measures
   Open-label USL255 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 37.5  (11.09) 
[Units: Participants]
Female   114 
Male   96 

  Outcome Measures

1.  Primary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Bob Anders, Sr. Director of Clinical Operations
Organization: Upsher-Smith Laboratories, Inc.
phone: 763-315-2000

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