Clinical trial NCT00655551: Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Official title: A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Epilepsies
Partial Onset Seizures
Keywords: epilepsy
seizures
Lacosamide
Vimpat
intravenous
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.

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

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
timeFrame: Treatment period (up to 7 days)
measure: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
timeFrame: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
Secondary outcomes:
measure: Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion
timeFrame: 0-4 hours post start of the infusion
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Baltimore
country: United States
state: Maryland
city: Chesterfield
country: United States
state: Missouri
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Fountain NB, Krauss G, Isojarvi J, Dilley D, Doty P, Rudd GD. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures. Epilepsia. 2013 Jan;54(1):58-65. doi: 10.1111/j.1528-1167.2012.03543.x. Epub 2012 Jun 18.