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

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655551
• Other study ID #: SP0925
• Secondary ID: 2014-004378-40
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsies
• Partial Onset Seizures
• Seizures

Intervention

Drug:
• lacosamide
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
• lacosamide
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
• lacosamide
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB BIOSCIENCES, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.1528-1167.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Treatment period (up to 7 days)
Primary	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).	Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
Secondary	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).	0-4 hours post start of the infusion

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