We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01146951
First Posted: June 22, 2010
Last Update Posted: March 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
Results First Submitted: May 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lennox-Gastaut Syndrome
Interventions: Drug: Rufinamide (E2080)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01146951     History of Changes
Other Study ID Numbers: E2080-J081-304
First Submitted: June 14, 2010
First Posted: June 22, 2010
Results First Submitted: May 13, 2013
Results First Posted: November 21, 2013
Last Update Posted: March 5, 2014