Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

This study has been completed.

Study NCT00419393 Information provided by UCB, Inc.

First Received on January 4, 2007. Last Updated on August 30, 2011 History of Changes

Results First Received: March 25, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Epilepsy
Intervention:	Drug: Keppra XR (Levetiracetam XR)

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
The study began December 2007 recruiting in the United States, Poland, Mexico, and the Russian Federation. The study completed March 2010.

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
Keppra XR (Levetiracetam XR)	1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

Participant Flow: Overall Study

	Keppra XR (Levetiracetam XR)
STARTED	190 ^[1]
COMPLETED	166
NOT COMPLETED	24
Adverse Event	5
Protocol Violation	5
Withdrawal by Subject	7
Other: Sponsor request	3
Other: Subject had temporal lobectomy	1
Other: Site closure	1
Other: Other health problems	1
Other: Investigator decision	1

[1]	One subject did not receive medication

Baseline Characteristics

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Reporting Groups

	Description
Keppra XR (Levetiracetam XR)	1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

Baseline Measures

	Keppra XR (Levetiracetam XR)
Number of Participants [units: participants]	190
Age [units: participants]
<=18 years	40
Between 18 and 65 years	147
>=65 years	3
Age [units: years] Mean ± Standard Deviation	33.44 ± 14.46
Gender [units: participants]
Female	111
Male	79
Region of Enrollment [units: participants]
United States	26
Mexico	49
Poland	59
Russian Federation	56

Outcome Measures

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1. Primary:

Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) [ Time Frame: Duration of the Treatment Period (6 months-2 years) ]

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2. Primary:

Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) [ Time Frame: Duration of the Treatment Period (6 months-2 years) ]

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3. Primary:

Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period [ Time Frame: Duration of the Treatment Period (6 months-2 years) ]

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4. Secondary:

Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months [ Time Frame: Study entry through 6 months ]

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5. Secondary:

Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months [ Time Frame: Study entry through 12 months ]

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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: UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.

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: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00419393 History of Changes
Other Study ID Numbers:	N01281
Study First Received:	January 4, 2007
Results First Received:	March 25, 2011
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health; Mexico: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation