A Phase 3 interventional study of Levetiracetam in Epilepsy, Tonic-clonic, sponsored by UCB Pharma SA. Completed at 22 sites in 4 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by UCB Pharma SA (part of UCB S.A.) · Phase 3, Interventional, and Treatment
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
23 studies on the registry are indexed under Epilepsy, Tonic-Clonic; 3 are open to participants now.
This study's enrollment of 66 is below the median of 94 across 20 interventional studies indexed under Epilepsy, Tonic-Clonic.
Browse Epilepsy, Tonic-Clonic studies →UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects received open-label Levetiracetam.
Drug: Levetiracetam
Pharmaceutical form: oral tablets Route of administration: Oral use
Also known as: Keppra
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
The study started to enroll patients in August 2005 and concluded in May 2007.
| Milestone | Levetiracetam |
|---|---|
| Started | 66 |
| Completed | 48 |
| Not completed | 18 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Remission | 3 |
| Withdrew: Planned pregancy | 1 |
| Withdrew: Switch to commercially available lev | 2 |
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).
| percentage of participants | Levetiracetam |
|---|---|
| Percentage Participants With Treatment Emergent Adverse Events | 27.3 |
Collected over Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levetiracetam | — | 4/66 (6.1%) | 0/66 (0%) |
| Event | Levetiracetam |
|---|---|
| EncephalopathyNervous system disorders | 1/66 |
| PolyneuropathyNervous system disorders | 1/66 |
| EpilepsyNervous system disorders | 1/66 |
| Completed suicideNervous system disorders | 1/66 |
Baseline Characteristics refer to the Intention-to-Treat (ITT) population.
| Age, Categorical(Participants) | Levetiracetam |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 56 |
| >=65 years | 10 |
| Age, Continuous(years) | Levetiracetam |
|---|---|
| Mean | 41.39 ± 18.27 |
| Sex: Female, Male(Participants) | Levetiracetam |
|---|---|
| Female | 31 |
| Male | 35 |
Plan to share: No
Ran from Aug 2005 to primary completion in May 2007, 21 months.
Results were first posted in Oct 2018, 11 years 4 months after primary completion.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levetiracetam