Phase 3
Completed N=100
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Partial Epilepsies · Partial-Onset Seizures
Source: ClinicalTrials.gov NCT00655551 ↗
Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Oct 2010
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days) — 17; 42; 20 subjects
Summary
The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days) |
17; 42; 20 | — |
| PRIMARY Number of Subjects Who Withdrew From the Trial Due to an Adverse Event |
0; 3; 4 | — |
| SECONDARY Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion |
5; 24; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
- Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
- Acceptable candidate for venipuncture and intravenous (iv) infusion
- At least 1 partial seizure with motor component per 90 days
- Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type
Exclusion Criteria
- Previous use of lacosamide
- History of primary generalized seizures
- History of status epilepticus within last 12 months
- History of cluster seizures during 8 week period prior to screening
- Non-epileptic events, including psychogenic seizures that could be confused with seizures
- Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
- Received any rescue benzodiazepines more than once during the 28 days prior to screening
- Concomitant treatment of felbamate or previous felbamate therapy within last 6 months
- Prior or concomitant vigabatrin use
Data sourced from ClinicalTrials.gov (NCT00655551). 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.