Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

• ClinicalTrials.gov Identifier: NCT00150813
• Recruitment Status: Completed
• First Posted: September 8, 2005
• Results First Posted: October 1, 2018
• Last Update Posted: November 21, 2018
• Sponsor: UCB Pharma SA
• Information provided by (Responsible Party): UCB Pharma ( UCB Pharma SA )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy, Tonic-clonic
• Intervention: Drug: Levetiracetam
• Enrollment: 66

Participant Flow

Recruitment Details	The study started to enroll patients in August 2005 and concluded in May 2007.
Pre-assignment Details	Participant Flow refers to the Intention-to-Treat (ITT) Set.

Arm/Group Title	Levetiracetam
Arm/Group Description	Subjects received open-label Levetiracetam.
Period Title: Overall Study
Started	66
Completed	48
Not Completed	18
Reason Not Completed
Adverse Event	1
Lack of Efficacy	1
Lost to Follow-up	5
Withdrawal by Subject	5
Remission	3
Planned pregancy	1
Switch to commercially available LEV	2

Baseline Characteristics

Arm/Group Title		Levetiracetam
Arm/Group Description		Subjects received open-label Levetiracetam.
Overall Number of Baseline Participants		66
Baseline Analysis Population Description		Baseline Characteristics refer to the Intention-to-Treat (ITT) population.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	66 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	56 84.8%
	>=65 years	10 15.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	66 participants
		41.39 (18.27)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	66 participants
	Female	31 47.0%
	Male	35 53.0%

Outcome Measures

1. Primary Outcome

Title	Percentage Participants With Treatment Emergent Adverse Events
Description	An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame	From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Levetiracetam
Arm/Group Description:	Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed	66
Measure Type: Number; Unit of Measure: percentage of participants
	27.3

Adverse Events

Time Frame	Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Levetiracetam
Arm/Group Description	Subjects received open-label Levetiracetam.
All-Cause Mortality
	Levetiracetam
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Levetiracetam
	Affected / at Risk (%)
Total	4/66 (6.06%)
Nervous system disorders
Encephalopathy * 1	1/66 (1.52%)
Polyneuropathy * 1	1/66 (1.52%)
Epilepsy * 1	1/66 (1.52%)
Completed suicide * 1	1/66 (1.52%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Levetiracetam
	Affected / at Risk (%)
Total	0/66 (0.00%)

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.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

• Responsible Party: UCB Pharma ( UCB Pharma SA )
• ClinicalTrials.gov Identifier: NCT00150813
• Other Study ID Numbers: N01127
• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Results First Submitted: February 8, 2018
• Results First Posted: October 1, 2018
• Last Update Posted: November 21, 2018