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A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01228747
First received: October 22, 2010
Last updated: May 29, 2015
Last verified: May 2015
Results First Received: April 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Epilepsy
Generalized Tonic-Clonic Seizures
Interventions: Drug: Levetiracetam
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 started to enroll subjects in Japan and China in October 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow refers to the Randomized Set consisting of all screened subjects who signed the Informed Consent form, participated in the prospective Baseline Period and were randomized at Visit 2.

Reporting Groups
  Description
Placebo

Matching placebo for 28 weeks

Placebo: Matching oral placebo tablets twice daily for 28 weeks

Levetiracetam

Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Levetiracetam: Oral dose tablets, twice daily


Participant Flow:   Overall Study
    Placebo   Levetiracetam
STARTED   125   126 
COMPLETED   60   81 
NOT COMPLETED   65   45 
Adverse Event                8                4 
Lack of Efficacy                40                27 
Protocol Violation                6                5 
Lost to Follow-up                4                3 
Withdrawal by Subject                5                1 
Other Reason                2                5 



  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.
Baseline Characteristics refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Placebo or Levetiracetam.

Reporting Groups
  Description
Placebo

Matching placebo for 28 weeks

Placebo: Matching oral placebo tablets twice daily

Levetiracetam

Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Levetiracetam: Oral dose tablets, twice daily

Total Total of all reporting groups

Baseline Measures
   Placebo   Levetiracetam   Total 
Overall Participants Analyzed 
[Units: Participants]
 125   126   251 
Age 
[Units: Participants]
     
<=18 years   11   10   21 
Between 18 and 65 years   113   115   228 
>=65 years   1   1   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.8  (12.5)   31.5  (11.3)   32.2  (11.9) 
Gender 
[Units: Participants]
     
Female   49   47   96 
Male   76   79   155 
Region of Enrollment 
[Units: Participants]
     
China   104   104   208 
Japan   21   22   43 


  Outcome Measures
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1.  Primary:   Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)   [ Time Frame: From Baseline to Week 28 ]

2.  Secondary:   The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period   [ Time Frame: From Baseline to Evaluation Period (Week 12 to Week 28) ]

3.  Secondary:   Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period   [ Time Frame: From Baseline to Week 28 ]

4.  Secondary:   Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period   [ Time Frame: From Baseline to Evaluation Period (Week 12 to Week 28) ]

5.  Secondary:   Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period   [ Time Frame: Evaluation Period (Week 12 to Week 28) ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)



Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01228747     History of Changes
Other Study ID Numbers: N01159
2014-004401-32 ( EudraCT Number )
Study First Received: October 22, 2010
Results First Received: April 27, 2015
Last Updated: May 29, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare
China: Food and Drug Administration