Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

• ClinicalTrials.gov Identifier: NCT00291655
• Recruitment Status: Completed
• First Posted: February 14, 2006
• Results First Posted: November 13, 2009
• Last Update Posted: May 18, 2015
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Levetiracetam
• Enrollment: 130

Participant Flow

Recruitment Details	Participants Flow describes all subjects treated at least once during open-label monotherapy with Levetiracetam.
Pre-assignment Details

Arm/Group Title	Levetiracetam Open- Label Treatment
Arm/Group Description	Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Period Title: Overall Study
Started	130
Completed	115
Not Completed	15

Baseline Characteristics

Arm/Group Title		Levetiracetam Open- Label Treatment
Arm/Group Description		Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Overall Number of Baseline Participants		130
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	130 participants
		40.68 (18.35)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	130 participants
	Female	58 44.6%
	Male	72 55.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	130 participants
France		18
Finland		9
Poland		32
Belgium		25
Bulgaria		31
Switzerland		15

Outcome Measures

1. Primary Outcome

Title	Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
Description	Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
Time Frame	during open-label therapy phase of 18 months

Outcome Measure Data

Analysis Population Description

Safety population that includes all subjects that have been treated once.

Arm/Group Title	Levetiracetam Open- Label Treatment
Arm/Group Description:	Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Overall Number of Participants Analyzed	130
Measure Type: Number; Unit of Measure: participants
Subjects with at least one AE	40
Subjects with AEs leading to dose change	8
Subjects with AEs leading to trial discontinuation	1
Subjects with drug-related AEs	16
Subjects with AEs of severe intensity	4
Subjects with serious AEs	6
Subjects with study drug-related serious AEs	0
Number of deaths	0

2. Secondary Outcome

Title	Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
Description	[Not Specified]
Time Frame	Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months

Outcome Measure Data

Analysis Population Description

Subjects with a discontinuation visit

Arm/Group Title	Levetiracetam Open- Label Treatment
Arm/Group Description:	Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Overall Number of Participants Analyzed	79
Mean (Standard Deviation); Unit of Measure: kg
	0.71 (3.16)

Adverse Events

Time Frame	Open-label treatment over 18 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Levetiracetam Open- Label Treatment
Arm/Group Description	Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
All-Cause Mortality
	Levetiracetam Open- Label Treatment
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Levetiracetam Open- Label Treatment
	Affected / at Risk (%)	# Events
Total	6/130 (4.62%)
Cardiac disorders
Acute coronary syndrome * 1	1/130 (0.77%)	1
Hepatobiliary disorders
Hepatic cirrhosis * 1	1/130 (0.77%)	1
Infections and infestations
Tonsillitis * 1	1/130 (0.77%)	1
Injury, poisoning and procedural complications
Skin laceration * 1	1/130 (0.77%)	1
Foot fracture * 1	1/130 (0.77%)	1
Nervous system disorders
Grand mal convulsion * 1	1/130 (0.77%)	1
Psychiatric disorders
Alcoholism * 1	1/130 (0.77%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, medDRA 9.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Levetiracetam Open- Label Treatment
	Affected / at Risk (%)	# Events
Total	10/130 (7.69%)
Investigations
Weight decreased * 1	3/130 (2.31%)	3
Weight increased * 1	7/130 (5.38%)	7
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 9.0

Limitations and Caveats

[Not Specified]

More Information

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.

UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that 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 results shall be published regardless of outcome.

Results Point of Contact

• Name/Title: UCB Clinical trial call center
• Organization: UCB Pharma
• Phone: +1 877 822 9493

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00291655
• Other Study ID Numbers: N01237; EUDRACT NUMBER: 2006-000173-29
• First Submitted: February 10, 2006
• First Posted: February 14, 2006
• Results First Submitted: August 25, 2009
• Results First Posted: November 13, 2009
• Last Update Posted: May 18, 2015