Phase 3
Completed N=66
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
Epilepsy, Tonic-clonic
Source: ClinicalTrials.gov NCT00150813 ↗
Enrolled (actual)
66
Serious AEs
6.1%
Results posted
Oct 2018
Primary outcomePrimary: Percentage Participants With Treatment Emergent Adverse Events — 27.3 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Participants With Treatment Emergent Adverse Events |
27.3 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00150813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.