Phase 3
Completed N=313
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
Epilepsies · Partial
Source: ClinicalTrials.gov NCT00367432 ↗
Enrolled (actual)
313
Serious AEs
16.1%
Results posted
Jan 2012
Primary outcomePrimary: Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted) — 381 participants
Summary
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 [NCT00160165] or N01221 [NCT00280696].
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted) |
381 | — |
| SECONDARY Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study |
22.00 | — |
| SECONDARY Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study |
2.13 | — |
| SECONDARY Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221) |
74; 239 | — |
| SECONDARY Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study |
39.84 | — |
| SECONDARY Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study |
20.59 | — |
| SECONDARY Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study |
76.56 | — |
| SECONDARY Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study |
20.71 | — |
| SECONDARY Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study |
66.47 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615]
Exclusion Criteria
- Female patients during pregnancy, delivery and lactation, or suspected of pregnancy
Data sourced from ClinicalTrials.gov (NCT00367432). 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.