Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

Conditions: Partial Epilepsies Partial Onset Seizures
MedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-004378-40-Outside-EU/EEA

Lead Sponsor: CB BIOSCIENCES Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 100

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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