Epilepsy, Tonic-clonic
Conditions
Keywords
Monotherapy, Epilepsy, Keppra, Levetiracetam
Brief summary
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
Interventions
DRUGLevetiracetam
Pharmaceutical form: oral tablets Route of administration: Oral use
Sponsors
UCB Pharma SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with a confirmed diagnosis of epilepsy. * Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures * Subjects having participated in the previous double-blind monotherapy trial (N01061 \[NCT00150735\] or N01093 \[NCT00150787\]). * Male/female subjects (\>= 16 years).
Exclusion criteria
\- Need for an additional Antiepileptic Drug (AED).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Participants With Treatment Emergent Adverse Events | From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks | 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). |
Countries
Czechia, Hungary, Poland, Sweden
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.
Participants by arm
| Arm | Count |
|---|---|
| Levetiracetam Subjects received open-label Levetiracetam. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Planned pregancy | 1 |
| Overall Study | Remission | 3 |
| Overall Study | Switch to commercially available LEV | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Levetiracetam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Age, Continuous | 41.39 years STANDARD_DEVIATION 18.27 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 4 / 66 |
Outcome results
Primary
Percentage Participants With Treatment Emergent Adverse Events
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
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levetiracetam | Percentage Participants With Treatment Emergent Adverse Events | 27.3 percentage of participants |