Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01191086
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: Endpoint Classification: Safety Study;   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
No text entered.

Reporting Groups
  Description
Open-label USL255

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

USL255


Participant Flow:   Overall Study
    Open-label USL255  
STARTED     210  
COMPLETED     148  
NOT COMPLETED     62  
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.
No text entered.

Reporting Groups
  Description
Open-label USL255

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

USL255


Baseline Measures
    Open-label USL255  
Number of Participants  
[units: participants]
  210  
Age  
[units: years]
Mean ± Standard Deviation
  37.5  ± 11.09  
Gender  
[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
e-mail: bob.anders@upsher-smith.com


No publications provided


Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration