Back to resultsSafety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Primary Purpose
Partial Epilepsies, Partial Onset Seizures
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lacosamide
lacosamide
lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Partial Epilepsies focused on measuring epilepsy, seizures, Lacosamide, Vimpat, intravenous
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Lacosamide 200 mg cohort
Lacosamide 300 mg combined cohorts
Lacosamide 400 mg cohort
Arm Description
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Outcomes
Primary Outcome Measures
Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Secondary Outcome Measures
Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655551
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsies, Partial Onset Seizures
Keywords
epilepsy, seizures, Lacosamide, Vimpat, intravenous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide 200 mg cohort
Arm Type
Experimental
Arm Description
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Arm Title
Lacosamide 300 mg combined cohorts
Arm Type
Experimental
Arm Description
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Arm Title
Lacosamide 400 mg cohort
Arm Type
Experimental
Arm Description
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
Description
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame
Treatment period (up to 7 days)
Title
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Description
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame
Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
Secondary Outcome Measure Information:
Title
Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion
Description
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame
0-4 hours post start of the infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Chesterfield
State/Province
Missouri
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22708895
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.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/Recalls/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
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