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

NCT00655551 | Completed Phase 3 Results DMC

• 2 other identifiers: SP09252014-004378-40
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

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.

Conditions

Partial Epilepsies; Partial Onset Seizures

Keywords

epilepsy; seizures; Lacosamide; Vimpat; intravenous

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion

  0-4 hours post start of the infusion

Study Arms (3)

Lacosamide 200 mg cohort

EXPERIMENTAL

Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily

Drug: lacosamide

Lacosamide 300 mg combined cohorts

EXPERIMENTAL

Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily

Drug: lacosamide

Lacosamide 400 mg cohort

EXPERIMENTAL

Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily

Drug: lacosamide

Interventions

lacosamide DRUG

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

Also known as: Vimpat

Lacosamide 200 mg cohort

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB BIOSCIENCES, Inc.: lead

Study Sites (7)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Chesterfield, Missouri, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Related 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.1528-1167.2012.03543.x. Epub 2012 Jun 18.

  PMID: 22708895 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Seizures

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB, Inc

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 17, 2018
• Results First Posted: October 20, 2010

Record last verified: 2017-07

Locations

US (7)