Clobazam in Patients With Lennox-Gastaut Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lundbeck LLC
ClinicalTrials.gov Identifier:
NCT00518713
First received: August 20, 2007
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 Medium Dose
Drug: Clobazam High Dose
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
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Reporting Groups
  Description
Clobazam Low Dose 0.25 mg/kg/day; tablets; orally; for 15-18 weeks
Clobazam Medium Dose 0.5 mg/kg/day; tablets; orally; for 15-18 weeks
Clobazam High Dose 1.0 mg/kg/day; tablets; orally; for 15-18 weeks
Placebo tablets; orally; daily for 15-18 weeks

Participant Flow:   Overall Study
    Clobazam Low Dose     Clobazam Medium Dose     Clobazam High Dose     Placebo  
STARTED     58     62     59     59  
Modified Intent-to-Treat Population     53     58     49     57  
COMPLETED     50     45     41     41  
NOT COMPLETED     8     17     18     18  



  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.
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Reporting Groups
  Description
Clobazam Low Dose 0.25 mg/kg/day; tablets; orally; for 15-18 weeks
Clobazam Medium Dose 0.5 mg/kg/day; tablets; orally; for 15-18 weeks
Clobazam High Dose 1.0 mg/kg/day; tablets; orally; for 15-18 weeks
Placebo tablets; orally; daily for 15-18 weeks
Total Total of all reporting groups

Baseline Measures
    Clobazam Low Dose     Clobazam Medium Dose     Clobazam High Dose     Placebo     Total  
Number of Participants  
[units: participants]
  58     62     59     59     238  
Age  
[units: participants]
         
<=18 years     48     48     49     48     193  
Between 18 and 65 years     10     14     10     11     45  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  10.9  ± 7.24     14.1  ± 10.42     11.7  ± 8.48     13.0  ± 9.17     12.4  ± 8.96  
Gender  
[units: participants]
         
Female     22     26     25     21     94  
Male     36     36     34     38     144  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).   [ Time Frame: 4-week baseline period and 12-week maintenance period ]

2.  Secondary:   Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).   [ Time Frame: 4-week baseline period and the first 4 weeks of the 12-week maintenance period ]

3.  Secondary:   Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).   [ Time Frame: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period ]

4.  Secondary:   Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).   [ Time Frame: 4-week baseline period and the last 4 weeks of the 12-week maintenance period ]

5.  Secondary:   Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).   [ Time Frame: 4-week baseline period and the 12-week maintenance period ]

6.  Secondary:   Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).   [ Time Frame: 4-week baseline period and the first 4 weeks of the 12-week maintenance period ]

7.  Secondary:   Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).   [ Time Frame: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period ]

8.  Secondary:   Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).   [ Time Frame: 4-week baseline period and the last 4 weeks of the 12-week maintenance period ]

9.  Secondary:   Tolerance   [ Time Frame: 4-week baseline period and first 4/first 8 weeks of the maintenance period ]

10.  Secondary:   Investigator Global Evaluations of the Patient's Overall Change in Symptoms.   [ Time Frame: Week 15 ]

11.  Secondary:   Parent/Caregiver Global Evaluations of the Patient’s Overall Change in Symptoms.   [ Time Frame: Week 15 ]

12.  Other Pre-specified:   Percent Reduction in the Number of Non-drop Seizures.   [ Time Frame: 4-week baseline period and the 12-week maintenance period ]

13.  Other Pre-specified:   Percent Reduction of Total (Drop and Non-Drop) Seizures.   [ Time Frame: 4-week baseline period and 12-week maintenance 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 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.


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


Publications of Results:
Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA, on behalf of the OV-1012 Study Investigators. Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology 77(15): 1473-1481, 2011.


Responsible Party: Lundbeck LLC
ClinicalTrials.gov Identifier: NCT00518713     History of Changes
Other Study ID Numbers: 13110A, OV1012
Study First Received: August 20, 2007
Results First Received: November 7, 2011
Last Updated: January 6, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belarus: Ministry of Health
India: Drugs Controller General of India
Lithuania: State Medicine Control Agency - Ministry of Health
United States: Food and Drug Administration