Phase 2
Completed N=16
An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures
Source: ClinicalTrials.gov NCT01407523 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days) — 5 participants
Summary
To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days) |
5 | — |
| PRIMARY Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days) |
— | — |
| SECONDARY Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 |
11.732 | — |
| SECONDARY Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 |
11.632 | — |
| SECONDARY Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 |
6.611 | — |
| SECONDARY Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 |
5.492 | — |
| SECONDARY Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period |
0.38 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is a male or female aged ≥ 16 years
- Subject has Partial Onset Seizures that are classifiable according to the 1981 International League Against Epilepsy (ILAE) classification of Epileptic Seizures
- Subject weighs ≥ 40 kg
- Subject is currently taking Levetiracetam (LEV) as an adjunctive antiepileptic oral treatment with 1 to 3 other Antiepileptic Drugs (AEDs)
Exclusion Criteria
- Subject has problems with venous accessibility
- Subject has participated in another clinical/pharmacological study during the last 4 weeks prior to the Screening Visit
- Subject is pregnant or lactating
- Subject has a history of suicide attempt(s) or presents with current depressive signs, current suicidal ideation, and/or behavior
- Subject has clinically significant Electrocardiogram (ECG) abnormalities according to the investigator
Data sourced from ClinicalTrials.gov (NCT01407523). 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.