Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01091662
First received: March 17, 2010
Last updated: November 16, 2015
Last verified: November 2015
Results First Received: October 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Eslicarbazepine acetate 1600 mg
Drug: Eslicarbazepine acetate 1200 mg

  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
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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
  Description
ESL 1200 mg Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
ESL1600 mg Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.

Participant Flow:   Overall Study
    ESL 1200 mg     ESL1600 mg  
STARTED     58     114  
COMPLETED     41     80  
NOT COMPLETED     17     34  
Adverse Event                 1                 9  
Physician Decision                 1                 1  
Withdrawal by Subject                 7                 6  
met exit criteria                 7                 13  
met exclusion criteria                 1                 0  
Lost to Follow-up                 0                 1  
Pregnancy                 0                 1  
Protocol Violation                 0                 2  
unable to swallow capsule                 0                 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
  Description
ESL1200 mg Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
ESL 1600 mg Subjects randomized to 1600 mg QD of eslicarbazepineacetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Total Total of all reporting groups

Baseline Measures
    ESL1200 mg     ESL 1600 mg     Total  
Number of Participants  
[units: participants]
  58     114     172  
Age  
[units: participants]
     
<=18 years     3     4     7  
Between 18 and 65 years     55     110     165  
>=65 years     0     0     0  
Age, Customized  
[units: participants]
     
<18 years     3     4     7  
18-39 years     32     59     91  
40-65 years     23     51     74  
>65 years     0     0     0  
Gender  
[units: participants]
     
Female     27     62     89  
Male     31     52     83  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     7     8  
Not Hispanic or Latino     57     107     164  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Czech Republic     11     22     33  
United States     15     28     43  
Ukraine     26     42     68  
Bulgaria     6     19     25  
Serbia     0     3     3  



  Outcome Measures
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1.  Primary:   Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method   [ Time Frame: From beginning of Week 3 to end of Week 18 ]

2.  Secondary:   Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.   [ Time Frame: Week 9 through 18 ]

3.  Secondary:   Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.   [ Time Frame: Week 15 through 18 ]

4.  Secondary:   Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment).   [ Time Frame: 18 weeks ]

5.  Secondary:   Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete).   [ Time Frame: Week 8 through 18 ]

6.  Secondary:   Time on Eslicarbazepine Acetate Monotherapy.   [ Time Frame: Week 8 to Week 18 ]

7.  Secondary:   Change in Seizure Frequency From Baseline.   [ Time Frame: 18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy; weeks 9 to 18 ]

8.  Secondary:   Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).   [ Time Frame: Week 0 to Week 18, Double-blind weeks 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18 ]

9.  Secondary:   Proportion (%) of Subjects Reaching Each Exit Criteria   [ Time Frame: Week 1 to Week 18, (beginning of week 1 to end of week 18) ]

10.  Secondary:   Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).   [ Time Frame: Week 0 to Week 18, Baseline: Day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18 ]

11.  Secondary:   Change in Total Score in Montgomery-Asberg Depression Rating Scale (MADRS),From Baseline .   [ Time Frame: Week 0 to Week 18,baseline day 0; end of AED taper/conversion period; end of week 8; end of monotherapy period; end of week 18 ]

12.  Secondary:   Change in Total Score of MADRS From Baseline in Those Subjects With a MADRS Score of ≥14 at Randomization.   [ Time Frame: Week 0 to Week 18, baseline:day 0;end of AED taper/conversion period; end of week 8; end of monotherapy period: end of week 18 ]

13.  Secondary:   Proportion (%) of Subjects With Increase of Body Weight >= 7% From Baseline   [ Time Frame: 18 Week Double-blind treatment period ]

14.  Secondary:   Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L.   [ Time Frame: Week 0 to Week 18 ]

15.  Secondary:   Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).   [ Time Frame: 18 Week Double-blind treatment period ]

16.  Secondary:   Standardized Seizure Frequency (SSF) by Period   [ Time Frame: Double-blind: week to 18; Baseline: weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion weeks 3 to 8; monotherapy: weeks 9 to 18 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Eslicarbazepine acetate Medical Director
Organization: Sunovion Phamaceuticals Inc.
phone: 866-503-7813
e-mail: clinicaltrialsdisclosure@sunovion.com


Publications:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01091662     History of Changes
Other Study ID Numbers: 093-046
Study First Received: March 17, 2010
Results First Received: October 2, 2015
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration