Phase 3
Completed N=151
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
Epilepsy, Partial
Source: ClinicalTrials.gov NCT00160615 ↗
Enrolled (actual)
151
Serious AEs
22.5%
Results posted
Jun 2019
Primary outcomePrimary: Partial (Type I) Seizure Frequency Per Week by Analysis Visit — 1.68; 2.19; 1.69; 2.00 Number of Seizures (Type I) per week
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Partial (Type I) Seizure Frequency Per Week by Analysis Visit |
1.68; 2.19; 1.69; 2.00; 1.58; 1.78 | — |
| PRIMARY Partial (Type IA) Seizure Frequency Per Week by Analysis Visit |
0.86; 0.68; 0.32; 0.83; 0.24; 0.63 | — |
| PRIMARY Partial (Type IB) Seizure Frequency Per Week by Analysis Visit |
1.56; 1.27; 1.51; 1.13; 1.30; 0.92 | — |
| PRIMARY Partial (Type IC) Seizure Frequency Per Week by Analysis Visit |
0.00; 0.00; 0.00; 0.00; 0.05; 0.00 | — |
| SECONDARY Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit |
-27.39; -31.24; -35.15; -34.74; -38.42; -43.03 | — |
| SECONDARY Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit |
-79.58; -45.93; -77.15; -58.81; -71.71; -61.62 | — |
| SECONDARY Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit |
-21.41; -26.77; -21.95; -31.35; -28.30; -47.61 | — |
| SECONDARY Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit |
-100.00; -100.00; -93.96; -100.00; -88.73; -100.00 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
- Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.
Exclusion Criteria
- Patients who had not participate in N165 Clinical Trial of L059.
- Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
- Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.
Data sourced from ClinicalTrials.gov (NCT00160615). 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.