A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01146951
First received: June 14, 2010
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: May 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lennox-Gastaut Syndrome
Interventions: Drug: Rufinamide (E2080)
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of n= 66 who started Observation Period, 7 discontinued from study. Primary reasons were deviation of the inclusion/ exclusion criteria (n=5), untoward event before study treatment (n=1) & other (n=1). Of 59 participants, 58 were included in full analysis set (FAS). 1 participant (E2080 group) was excluded due to inappropriate diagnosis of disease.

Reporting Groups
  Description
Rufinamide (E2080)

Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.

Target maintenance dose:

15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)

Placebo Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.

Participant Flow:   Overall Study
    Rufinamide (E2080)     Placebo  
STARTED     29     30  
COMPLETED     25     29  
NOT COMPLETED     4     1  
Adverse Event                 4                 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.
One subject from the Rufinamide (E2080) group was excluded from the FAS because of the inappropriate diagnosis of the disease, dropping the total number from 29 to 28 participants.

Reporting Groups
  Description
Rufinamide (E2080) Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
Placebo Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Rufinamide (E2080)     Placebo     Total  
Number of Participants  
[units: participants]
  28     30     58  
Age  
[units: years]
Mean ± Standard Deviation
  16.0  ± 7.1     13.9  ± 6.1     14.9  ± 6.6  
Gender  
[units: participants]
     
Female     11     11     22  
Male     17     19     36  



  Outcome Measures
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1.  Primary:   Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)   [ Time Frame: Baseline (28 day observational period) and End of Treatment (28 day treatment period) ]

2.  Secondary:   Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency   [ Time Frame: 12 weeks ]

3.  Secondary:   Percent Change in Total Seizure Frequency (Per 28 Days)   [ Time Frame: Baseline (28 day observational period) and End of Treatment (28 day treatment period) ]

4.  Secondary:   Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)   [ Time Frame: Baseline (28 day observational period) and End of Treatment (28 day treatment period) ]

5.  Secondary:   Clinical Global Impression of Change (CGIC)   [ Time Frame: Up to Week 12 of the treatment period ]


  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: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743


No publications provided


Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01146951     History of Changes
Other Study ID Numbers: E2080-J081-304
Study First Received: June 14, 2010
Results First Received: May 13, 2013
Last Updated: January 29, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare