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A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.

A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENERALIZED SEIZURES.

NCT01969851•UCB Pharma

View on ClinicalTrials.gov

Summary

SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in children with epilepsy syndromes associated with generalized seizures. LCM will be added to current antiepileptic treatment.

Detailed Description

SP0966 is a Phase 2, multicenter, open-label exploratory study designed to assess the safety and preliminary efficacy of oral lacosamide as adjunctive therapy for epilepsy syndromes associated with generalized seizures in pediatric subjects ≥1 month to \<18 years of age.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A signed informed consent has been obtained from the parent/legal representative and assent has been obtained from the subject (when possible)
•Subject and caregiver are willing and able to comply with all study requirements including maintaining a daily seizure diary
•Subject is male or female, ≥1 month to \<18 years of age
•Subject has a diagnosis of uncontrolled epilepsy with generalized seizures (Type II) according to the International Classification of Epileptic Seizures (1981). The underlying epilepsy syndrome should be documented. Diagnosis should have been established by clinical history and an Electroencephalogram (EEG) with generalized spike-wave discharges. Documentation of the EEG finding of generalized spike waves (EEG recording or a report) is required. The EEG should have been performed no more than 18 months prior to Visit 1 (with no change to diagnosis or seizure types during this time)
•Subject must have experienced 2 or more events (typical generalized seizures associated with diagnosed epilepsy syndrome) within the 6-week prospective Baseline Period
•Subject is on a stable dosage regimen of 1 to 3 antiepileptic drugs (AEDs). The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 4 weeks prior to the Baseline Period
•Vagal nerve stimulation is allowed and will not be counted as a concomitant AED. The vagus nerve stimulation (VNS) device must be implanted for at least 6 months before Visit 1, and the device settings must be stable for at least 4 weeks before Visit 1 and be kept stable during the Baseline Period and the Treatment Period. Use of the VNS device magnet is allowed
•Body weight at Visit 1 is at least 4 kg for infants.
•Females of childbearing potential must have a negative pregnancy test at Visit 1

Exclusion Criteria

•Subject has previously participated in this study, subject has been assigned to Lacosamide (LCM) in a previous LCM study, or subject has ever received LCM
•Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device
•Subject has a history of convulsive status epilepticus within 1 month prior to Visit 1
•Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures
•Subject has exclusively typical absence (Type IIA1) or atypical absence (Type IIA2) seizures (no other generalized seizure types are reported), or has only partial-onset seizures (Type I)
•Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this study
•Subject ≥6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
•Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP)
•Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion
•Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
+15 more criteria

Locations (18)

103

Los Angeles, California, United States

101

Orlando, Florida, United States

104

Henderson, Nevada, United States

112

Hackensack, New Jersey, United States

108

New Brunswick, New Jersey, United States

107

Akron, Ohio, United States

309

Ile-De-France, France

303

Lyon, France

701

Budapest, Hungary

702

Budapest, Hungary

Key Dates

Start Date

February 13, 2014

Primary Completion Date

April 10, 2018

Completion Date

April 10, 2018

Last Updated

May 7, 2019

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Lacosamide

DRUG

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Epilepsy; Seizure

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RECRUITINGPHASE1

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Epilepsy

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers