An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy

NCT ID: NCT00938912

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-09
• Study Completion Date: 2021-05-18

Brief Summary

SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.

Detailed Description

SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy. In addition, the study is designed to provide continued availability of LCM to subjects who have completed the SP847 (NCT00938431) study and to subjects who have discontinued from SP847 (NCT00938431) and who, in the investigator's opinion, would benefit from long-term administration of LCM.

SP848 will be open to subjects who have participated in other LCM pediatric clinical studies in epilepsy and will also be open to up to 100 subjects enrolling directly into SP848. Permissible LCM doses in SP848 are between 2-12 mg/kg/day (oral solution [syrup]) or the corresponding tablet dose up to a maximum dose of 600 mg/day.

Subjects enrolled in SP848 have the option of remaining on the oral solution formulation of LCM or switching to the commercial tablet formulation, if feasible.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lacosamide

Subjects and their caregivers may chose to receive Lacosamide oral solution (syrup) or Lacosamide tablets. The maximum duration of LCM administration will be approximately 2 years.

Group Type: EXPERIMENTAL

Lacosamide

Intervention Type: DRUG

Lacosamide oral solution (syrup): Total daily dose between 2 mg/kg/day (1 mg/kg bid) to 12 mg/kg/day (6 mg/kg bid)

Lacosamide

Intervention Type: DRUG

Lacosamide tablets: Total daily dose between 100 mg (50mg bid) - 600mg (300 mg bid).

The maximum permissible dose of LCM will be 12 mg/kg/day or 600 mg/day.

Interventions

Lacosamide

Lacosamide oral solution (syrup): Total daily dose between 2 mg/kg/day (1 mg/kg bid) to 12 mg/kg/day (6 mg/kg bid)

Intervention Type: DRUG

Lacosamide

Lacosamide tablets: Total daily dose between 100 mg (50mg bid) - 600mg (300 mg bid).

The maximum permissible dose of LCM will be 12 mg/kg/day or 600 mg/day.

Intervention Type: DRUG

Other Intervention Names

Vimpat®; Vimpat®

Eligibility Criteria

Inclusion Criteria

• A signed informed consent form has been obtained from the parent/legal guardian and assent has been obtained from the subject, as required
• Subject and caregiver (which may be a parent, legal guardian, or other delegated caregiver) are willing and able to comply with all study requirements, including maintaining a daily seizure diary

• Subject has completed SP847 (or the subject discontinued SP847 due to a dose reduction or status epilepticus) for the treatment of uncontrolled partial-onset seizures, or subject has participated in other LCM pediatric clinical studies in epilepsy
• Subject is expected to benefit from participation, in the opinion of the investigator

• Subject is >=4 years to <=17 years of age
• Subject has a diagnosis of epilepsy with partial-onset seizures
• Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with at least 2 Antiepileptic Drugs (AEDs) (concurrently or sequentially)
• Subject has been observed to have at least 2 countable seizures in the 4 week period prior to Screening
• Subject is on a stable dosage regimen of 1 to 3 AEDs
• Subject is an acceptable candidate for venipuncture

Exclusion Criteria

• Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
• Subject >= 6 years of age has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months

Subjects who have participated in SP847 or other LCM pediatric clinical studies in epilepsy are not permitted to enroll in the study if any of the following criteria are met:

• Subject meets either of the following:

1. Withdrawal criteria for the primary study (with the exception of subjects who discontinued due to a dose reduction or status epilepticus). For subjects entering from EP0060, if the subject (or legal guardian) withdraws consent solely due to route of LCM administration (iv) or if the subject requires more than 10 iv LCM infusions, the subject may be allowed to participant in SP848 after discussion with and agreement from the Medical Monitor

2. Ongoing serious Adverse Event (SAE)

Subjects who enroll directly into SP848 without previous participation in a LCM clinical study are not permitted to enroll in the study if any of the following criteria are met:

• Subject has ever received LCM
• Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
• Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion
• Subject has a known hypersensitivity to any component of the investigational medicinal product
• Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of the study
• Subject has a creatinine clearance less than 30mL/min
• Subject has a clinically relevant ECG abnormality, in the opinion of the principal investigator (ie, second or third degree heart block at rest or a QT prolongation greater than 450ms)
• Subject has hemodynamically significant heart disease (eg, heart failure)
• Subject has an arrhythmic heart condition requiring medical therapy
• Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
• Subject has nonepileptic events, including psychogenic seizures, that could be confused with seizures. If both epileptic and nonepileptic events are present, epileptic events must be distinguished from nonepileptic phenomena
• Subject has a history of primary generalized epilepsy
• Subject is taking monoamine oxidase inhibitors-A (MAOI-A) or narcotic analgesics.
• Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen syndrome
• Subject has a known sodium channelopathy, such as Brugada syndrome
• Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)

Subjects who were directly enrolled in EP0060 for iv LCM replacement therapy or to initiate LCM treatment are not permitted to enroll in the study if any of the following criteria are met:

• Subjects have previously participated in a long-term, open-label LCM study

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB BIOSCIENCES, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

+1 844 599 2273(UCB)

Locations

Sp848 064

Birmingham, Alabama, United States

Sp848 059

Los Angeles, California, United States

Sp848 025

Sacramento, California, United States

Sp848 002

Washington D.C., District of Columbia, United States

Sp848 054

Orlando, Florida, United States

Sp848 012

Tampa, Florida, United States

Sp848 019

Wellington, Florida, United States

Sp848 057

Augusta, Georgia, United States

Sp848 063

Saint Paul, Minnesota, United States

Sp848 006

Saint Paul, Minnesota, United States

Sp848 008

Kansas City, Missouri, United States

Sp848 061

Las Vegas, Nevada, United States

Sp848 062

Hackensack, New Jersey, United States

Sp848 015

New Brunswick, New Jersey, United States

Sp848 005

Durham, North Carolina, United States

Sp848 053

Akron, Ohio, United States

Sp848 068

Cincinnati, Ohio, United States

Sp848 001

Philadelphia, Pennsylvania, United States

Sp848 016

Pittsburgh, Pennsylvania, United States

Sp848 004

Nashville, Tennessee, United States

Sp848 026

Austin, Texas, United States

Sp848 067

Dallas, Texas, United States

Sp848 022

Houston, Texas, United States

Sp848 020

Norfolk, Virginia, United States

Sp848 201

Brussels, , Belgium

Sp848 200

Edegem, , Belgium

Sp848 203

Ghent, , Belgium

Sp848 202

Leuven, , Belgium

Sp848 950

Beijing, , China

Sp848 953

Changchun, , China

Sp848 951

Chongqing, , China

Sp848 955

Hanzhou, , China

Sp848 956

Nanchang, , China

Sp848 952

Shanghai, , China

Sp848 954

Shenzhen, , China

Sp848 309

Paris, , France

Sp848 304

Strasbourg, , France

Sp848 403

Kork, , Germany

Sp848 701

Budapest, , Hungary

Sp848 702

Budapest, , Hungary

Sp848 703

Budapest, , Hungary

Sp848 704

Budapest, , Hungary

Sp848 705

Debrecen, , Hungary

Sp848 503

Messina, , Italy

Sp848 502

Verona, , Italy

Sp848 257

Fukuoka, , Japan

Sp848 256

Hamamatsu, , Japan

Sp848 255

Kodaira, , Japan

Sp848 253

Kōshi, , Japan

Sp848 252

Niigata, , Japan

Sp848 258

Okayama, , Japan

Sp848 254

Osaka, , Japan

Sp848 259

Osaka, , Japan

Sp848 251

Shizuoka, , Japan

Sp848 101

Culiacán, , Mexico

Sp848 104

Guadalajara, , Mexico

Sp848 103

San Luis Potosí City, , Mexico

Sp848 803

Bialystok, , Poland

Sp848 807

Katowice, , Poland

Sp848 804

Kielce, , Poland

Sp848 801

Krakow, , Poland

Sp848 805

Lublin, , Poland

Sp848 224

Dnipro, , Ukraine

Sp848 225

Dnipro, , Ukraine

Sp848 220

Ivano-Frankivsk, , Ukraine

Sp848 221

Kiev, , Ukraine

Sp848 222

Kiev, , Ukraine

Sp848 226

Kiev, , Ukraine

Sp848 223

Vinnytsia, , Ukraine

Countries

United States; Belgium; China; France; Germany; Hungary; Italy; Japan; Mexico; Poland; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2011-001559-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP848

Identifier Type: -

Identifier Source: org_study_id