Trial Outcomes & Findings for Monotherapy With Levetiracetam in Patients Suffering From Epilepsy. (NCT NCT00150813)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

66 participants

Primary outcome timeframe

From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks

Results posted on

2018-11-21

Participant Flow

The study started to enroll patients in August 2005 and concluded in May 2007.

Participant Flow refers to the Intention-to-Treat (ITT) Set.

Participant milestones

Participant milestones
Measure	Levetiracetam Subjects received open-label Levetiracetam.
Overall Study STARTED	66
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Levetiracetam Subjects received open-label Levetiracetam.
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	5
Overall Study Remission	3
Overall Study Planned pregancy	1
Overall Study Switch to commercially available LEV	2

Baseline Characteristics

Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levetiracetam n=66 Participants Subjects received open-label Levetiracetam.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	41.39 years STANDARD_DEVIATION 18.27 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks

Population: Safety Set

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).

Outcome measures

Outcome measures
Measure	Levetiracetam n=66 Participants Subjects received open-label Levetiracetam.
Percentage Participants With Treatment Emergent Adverse Events	27.3 percentage of participants

Adverse Events

Levetiracetam

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Levetiracetam n=66 participants at risk Subjects received open-label Levetiracetam.
Nervous system disorders Encephalopathy	1.5% 1/66 • Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks.
Nervous system disorders Polyneuropathy	1.5% 1/66 • Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks.
Nervous system disorders Epilepsy	1.5% 1/66 • Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks.
Nervous system disorders Completed suicide	1.5% 1/66 • Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks.

Other adverse events

Adverse event data not reported

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60