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

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 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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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

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1. Primary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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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 ]

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13. Other Pre-specified:

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

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor must have the opportunity to review and approve all proposed abstracts, manuscripts, or presentations regarding this study prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.

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
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Results Point of Contact:

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

No publications provided

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

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