Study to Evaluate the Safety and Effectiveness 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:
NCT01142193
First received: June 9, 2010
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: April 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: USL255
Drug: Placebo

  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
This study was conducted in 16 countries (Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, Hungary, India, Israel, New Zealand, Poland, Russia, South Africa, Spain, and United States). At least 1 subject was enrolled at 66 study centers, of which 60 study centers randomly assigned at least 1 subject to study drug.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subject had to have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days during the 8-week baseline to be randomized into the trial.

Reporting Groups
  Description
USL255 Titration of 50 mg in weekly increments over 3 weeks to 200 mg
Placebo Placebo

Participant Flow:   Overall Study
    USL255     Placebo  
STARTED     124     125  
COMPLETED     103     114  
NOT COMPLETED     21     11  
Adverse Event                 12                 4  
Lack of Efficacy                 2                 1  
Physician Decision                 1                 1  
Withdrawal by Subject                 4                 3  
Protocol Discontinuation Criterion Met                 1                 0  
Other                 1                 2  



  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
USL255 Titration of 50 mg in weekly increments over 3 weeks to 200 mg
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    USL255     Placebo     Total  
Number of Participants  
[units: participants]
  124     125     249  
Age  
[units: Years]
Mean ± Standard Deviation
  37.6  ± 10.97     37.6  ± 11.11     37.6  ± 11.02  
Gender  
[units: participants]
     
Female     58     59     117  
Male     66     66     132  



  Outcome Measures
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1.  Primary:   Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.   [ Time Frame: 11 weeks ]

2.  Secondary:   Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.   [ Time Frame: 11 weeks ]

3.  Secondary:   Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.   [ Time Frame: 3 weeks (weeks 1-3) ]

4.  Secondary:   Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.   [ Time Frame: 3 weeks (weeks 1-3) ]

5.  Secondary:   Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.   [ Time Frame: 11 weeks ]

6.  Secondary:   Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.   [ Time Frame: 3 weeks (weeks 1-3) ]

7.  Secondary:   Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.   [ Time Frame: 11 weeks ]

8.  Secondary:   Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.   [ Time Frame: 8 weeks (weeks 4-11) ]

9.  Secondary:   Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.   [ Time Frame: 8 weeks (weeks 4-11) ]

10.  Secondary:   Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.   [ Time Frame: 8 weeks (weeks 4-11) ]


  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: NCT01142193     History of Changes
Other Study ID Numbers: P09-004, 2009-016996-31
Study First Received: June 9, 2010
Results First Received: April 3, 2014
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration