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.

NCT01969851 | Completed Phase 2 Results

• 2 other identifiers: SP09662012-001446-18
• Study Type: interventional
• Target: 55
• Locations: 5 countries
• Sites: 18

Brief 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.

Conditions

Epilepsy

Keywords

Lacosamide; Vimpat; Epilepsy; Children

Outcome Measures

Primary Outcomes (2)

• Mean Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 to Visit 6

  The mean change in the count of generalized spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.

  From Baseline (Day 1) to Visit 6 (Week 6)

• Mean Change in Days With Any Generalized Seizures (Absence, Myoclonic, Clonic, Tonic, Tonic-clonic, Atonic, Partial Evolving to Secondarily Generalized) Per 28 Days From the Baseline Period to the Maintenance Period (Approximately 24 Weeks)

  The mean change in the count of days with generalized seizures was presented.

  Baseline Period to the Maintenance Period (approximately 24 weeks)

Secondary Outcomes (3)

• Mean Changes in Count of 3 Hz Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory EEG From Visit 2 to Visit 6

  From Baseline (Day 1) to Visit 6 (Week 6)

• Number of Subject Withdrawals Due to Adverse Events From Baseline to End of Study (Approximately 32 Weeks)

  From Baseline to End of Study (approximately 32 weeks)

• Number of Subjects Experiencing at Least 1 Treatment-emergent Adverse Event From Baseline to End of Study (Approximately 32 Weeks)

  From Baseline to End of Study (approximately 32 weeks)

Study Arms (1)

Lacosamide

EXPERIMENTAL

Drug: Lacosamide

Interventions

Lacosamide DRUG

Oral intake twice daily of tablet (100 mg or 50 mg) or syrup formulation (10 mg/ml). Total daily dose will be titrated over a period of 6 weeks with starting dose of 100 mg/day or 2 mg/kg/day up to doses not exceeding 600 mg/day or 12 mg/kg/day tablet or syrup, respectively. Followed by a 12 week maintenance period with stable dosing of at least 200 mg/day or 4 mg/kg/day tablet or syrup, respectively.

Also known as: Vimpat

Lacosamide

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Subjects with West Syndrome are eligible if Baseline EEG demonstrates hypsarrhythmia despite treatment with at least 2 AEDs appropriate for the treatment of this syndrome

You may not qualify if:

• 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
• Subject has any history of alcohol or drug abuse within the previous 2 years
• Subject has an acute or sub-acutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome)
• Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥2x the upper limit of normal (ULN) or has alkaline phosphatase levels ≥3x ULN
• Subject has impaired renal function (ie, creatinine clearance is lower than 30 mL/min) at Visit 1
• Subject has sick sinus syndrome without a pacemaker, or second or third degree atrioventricular (AV) block

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (18)

103

Los Angeles, California, United States

Location

101

Orlando, Florida, United States

Location

104

Henderson, Nevada, United States

Location

112

Hackensack, New Jersey, United States

Location

108

New Brunswick, New Jersey, United States

Location

107

Akron, Ohio, United States

Location

309

Ile-De-France, France

Location

303

Lyon, France

Location

701

Budapest, Hungary

Location

702

Budapest, Hungary

Location

703

Budapest, Hungary

Location

704

Budapest, Hungary

Location

705

Debrecen, Hungary

Location

154

Guadalajara, Mexico

Location

807

Katowice, Poland

Location

801

Krakow, Poland

Location

805

Lublin, Poland

Location

802

Szczecin, Poland

Location

Related Publications (1)

• Auvin S, Arzimanoglou A, Beller C, Floricel F, Daniels T, Bozorg A. Safety, tolerability, and efficacy of adjunctive lacosamide in pediatric patients with epilepsy syndromes associated with generalized seizures: Phase 2, open-label exploratory trial. Epilepsia. 2023 Nov;64(11):2947-2957. doi: 10.1111/epi.17741. Epub 2023 Aug 23.

  PMID: 37545406 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsy

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  +1 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 25, 2013
• Study Start: February 13, 2014
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-05

Locations

PL (4); HU (5); FR (2); ME (1); US (6)