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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
History of Changes
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
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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
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
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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  
Number of Participants  
[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
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1.  Primary:   Percent Reduction in Number of Drop Seizures.   [ Time Frame: 4-week baseline period and 4-week maintenance period ]
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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 ]
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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 ]
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Measure Type Secondary
Measure Title Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in 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 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.
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

Measured Values
    Clobazam Low Dose     Clobazam High Dose  
Number of Participants Analyzed  
[units: participants]
 		  32     36  
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.  
[units: Percent of participants]
 		   
≥ 25% reduction     18     32  
≥ 50% reduction     12     30  
≥ 75% reduction     7     23  
100% reduction     2     8  

No statistical analysis provided for Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.



4.  Secondary:   Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.   [ Time Frame: Week 3 ]
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5.  Secondary:   Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.   [ Time Frame: Week 7 ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Email contact via H. Lundbeck A/S
Organization: Lundbeck LLC
e-mail: LundbeckClinicalTrials@lundbeck.com


Publications:


Responsible Party: Lundbeck LLC
ClinicalTrials.gov Identifier: NCT00162981     History of Changes
Other Study ID Numbers: 13108A, OV1002
Study First Received: September 9, 2005
Results First Received: November 7, 2011
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration