Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Clobazam in Subjects With Lennox-Gastaut Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lundbeck LLC
ClinicalTrials.gov Identifier:
NCT00162981
First received: September 9, 2005
Last updated: January 6, 2012
Last verified: January 2012
Results First Received: November 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Epilepsy
Epilepsy, Generalized
Seizures
Interventions: Drug: Clobazam Low Dose
Drug: Clobazam High Dose

  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
No text entered.

Reporting Groups
  Description
Clobazam Low Dose 5 to 10 mg/day with doses in the morning and at bedtime; orally
Clobazam High Dose 5 to 40 mg/day with doses in the morning and at bedtime; orally

Participant Flow:   Overall Study
    Clobazam Low Dose   Clobazam High Dose
STARTED   32   36 
COMPLETED   28   30 
NOT COMPLETED   4   6 
Adverse Event                2                5 
Withdrawal by Subject                1                1 
Physician Decision                1                0 



  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.
No text entered.

Reporting Groups
  Description
Clobazam Low Dose 5 to 10 mg/day with doses in the morning and at bedtime; orally
Clobazam High Dose 5 to 40 mg/day with doses in the morning and at bedtime; orally
Total Total of all reporting groups

Baseline Measures
   Clobazam Low Dose   Clobazam High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   36   68 
Age 
[Units: Participants]
     
<=18 years   30   33   63 
Between 18 and 65 years   2   3   5 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.18  (5.37)   8.51  (5.14)   8.82  (5.22) 
Gender 
[Units: Participants]
     
Female   13   13   26 
Male   19   23   42 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Reduction in Number of Drop Seizures.   [ Time Frame: 4-week baseline period and 4-week maintenance period ]

2.  Primary:   A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.   [ Time Frame: 4-week baseline period and the 4-week maintenance period ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
Measure Description Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Time Frame 4-week baseline period and the 4-week maintenance period  
Safety Issue No  

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.
MITT population

Reporting Groups
  Description
Clobazam Low Dose 5 to 10 mg/day with doses in the morning and at bedtime; orally
Clobazam High Dose 5 to 40 mg/day with doses in the morning and at bedtime; orally

Measured Values
   Clobazam Low Dose   Clobazam High Dose 
Participants Analyzed 
[Units: Participants]
 29   32 
A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. 
[Units: Percent Reduction]
Median (Full Range)
 29 
 (-531 to 100) 
 93 
 (48 to 100) 


Statistical Analysis 1 for A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] 1-sided Wilcoxon Rank-Sum Test
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Assuming a standard deviation of 50%, one-tailed significance at 0.05 and a power of 80% to detect a reduction of at least 25% (baseline to final in a within-subjects design), then approximately 27 subjects would have been required in each treatment arm. Assuming a 10% drop-out rate, then approximately 30 subjects per treatment were to be enrolled in the study.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  1-sided Wilcoxon Rank-Sum Test was used to compare the high dose group to the low dose group.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.   [ Time Frame: 4-week baseline period and 4-week maintenance period ]

4.  Secondary:   Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.   [ Time Frame: Week 3 ]

5.  Secondary:   Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.   [ Time Frame: Week 7 ]


  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