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

NCT00938912 | Completed Phase 2 Results

• 2 other identifiers: SP8482011-001559-35
• Study Type: interventional
• Target: 366
• Locations: 11 countries
• Sites: 69

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.

Conditions

Epilepsy

Keywords

Lacosamide (VIMPAT)

Outcome Measures

Primary Outcomes (3)

• Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)

  An AE is any untoward medical occurrence in a participant or clinical investigation study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.

  From Baseline to End of Safety Follow-Up (up to 4.3 years)

• Number of Participants With Serious Adverse Events (SAEs)

  SAE was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in participant hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment with parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.

  From Baseline to End of Safety Follow-Up (up to 4.3 years)

• Number of Participants That Withdraw Due to a Treatment-Emergent Adverse Event

  TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.

  From Baseline to End of Safety Follow-Up (up to 4.3 years)

Secondary Outcomes (5)

• Percent Change From Baseline in 28 Day Partial-onset Seizure Frequency to the End of the Treatment Period

  From Baseline to End of Treatment Period (up to 4.2 years)

• Percentage of Participants With ≥50% Reduction in 28-day Partial-onset Seizure Frequency

  From Baseline to End of Treatment Period (up to 4.2 years)

• Percentage of Participants With ≥75% Reduction in 28-day Partial-onset Seizure Frequency

  From Baseline to End of Treatment Period (up to 4.2 years)

• Number of Seizure Days Per 28 Days for Participants With Generalized Seizures

  Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 72, 84 and 96

• Percentage of Participants Who Achieved a Seizure-free Status

  From Baseline to End of Treatment Period (up to 4.2 years)

Study Arms (1)

Lacosamide

EXPERIMENTAL

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.

Drug: Lacosamide

Interventions

Lacosamide 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)

Also known as: Vimpat®

Lacosamide

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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)

Sponsors & Collaborators

• UCB BIOSCIENCES, Inc.: lead

Study Sites (69)

Sp848 064

Birmingham, Alabama, 35233, United States

Location

Sp848 059

Los Angeles, California, 90027-6062, United States

Location

Sp848 025

Sacramento, California, 95815, United States

Location

Sp848 002

Washington D.C., District of Columbia, 20010, United States

Location

Sp848 054

Orlando, Florida, 32819, United States

Location

Sp848 012

Tampa, Florida, 33609, United States

Location

Sp848 019

Wellington, Florida, 33470, United States

Location

Sp848 057

Augusta, Georgia, 30912-4005, United States

Location

Sp848 063

Saint Paul, Minnesota, 55101, United States

Location

Sp848 006

Saint Paul, Minnesota, 55102, United States

Location

Sp848 008

Kansas City, Missouri, 64108, United States

Location

Sp848 061

Las Vegas, Nevada, 89052, United States

Location

Sp848 062

Hackensack, New Jersey, 07601, United States

Location

Sp848 015

New Brunswick, New Jersey, 08901, United States

Location

Sp848 005

Durham, North Carolina, 27710, United States

Location

Sp848 053

Akron, Ohio, 44308, United States

Location

Sp848 068

Cincinnati, Ohio, 45229, United States

Location

Sp848 001

Philadelphia, Pennsylvania, 19104, United States

Location

Sp848 016

Pittsburgh, Pennsylvania, 15201, United States

Location

Sp848 004

Nashville, Tennessee, 37212, United States

Location

Sp848 026

Austin, Texas, 78723, United States

Location

Sp848 067

Dallas, Texas, 75235, United States

Location

Sp848 022

Houston, Texas, 77076, United States

Location

Sp848 020

Norfolk, Virginia, 23510, United States

Location

Sp848 201

Brussels, Belgium

Location

Sp848 200

Edegem, Belgium

Location

Sp848 203

Ghent, Belgium

Location

Sp848 202

Leuven, Belgium

Location

Sp848 950

Beijing, China

Location

Sp848 953

Changchun, China

Location

Sp848 951

Chongqing, China

Location

Sp848 955

Hanzhou, China

Location

Sp848 956

Nanchang, China

Location

Sp848 952

Shanghai, China

Location

Sp848 954

Shenzhen, China

Location

Sp848 309

Paris, France

Location

Sp848 304

Strasbourg, France

Location

Sp848 403

Kork, Germany

Location

Sp848 701

Budapest, Hungary

Location

Sp848 702

Budapest, Hungary

Location

Sp848 703

Budapest, Hungary

Location

Sp848 704

Budapest, Hungary

Location

Sp848 705

Debrecen, Hungary

Location

Sp848 503

Messina, Italy

Location

Sp848 502

Verona, Italy

Location

Sp848 257

Fukuoka, Japan

Location

Sp848 256

Hamamatsu, Japan

Location

Sp848 255

Kodaira, Japan

Location

Sp848 253

Kōshi, Japan

Location

Sp848 252

Niigata, Japan

Location

Sp848 258

Okayama, Japan

Location

Sp848 254

Osaka, Japan

Location

Sp848 259

Osaka, Japan

Location

Sp848 251

Shizuoka, Japan

Location

Sp848 101

Culiacán, Mexico

Location

Sp848 104

Guadalajara, Mexico

Location

Sp848 103

San Luis Potosí City, Mexico

Location

Sp848 803

Bialystok, Poland

Location

Sp848 807

Katowice, Poland

Location

Sp848 804

Kielce, Poland

Location

Sp848 801

Krakow, Poland

Location

Sp848 805

Lublin, Poland

Location

Sp848 224

Dnipro, Ukraine

Location

Sp848 225

Dnipro, Ukraine

Location

Sp848 220

Ivano-Frankivsk, Ukraine

Location

Sp848 221

Kiev, Ukraine

Location

Sp848 222

Kiev, Ukraine

Location

Sp848 226

Kiev, Ukraine

Location

Sp848 223

Vinnytsia, Ukraine

Location

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

001-844-599-2273

Study Officials

• UCB Cares

  +1 844 599 2273(UCB)

  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: July 10, 2009
• First Posted: July 14, 2009
• Study Start: December 9, 2009
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2021-12

Locations

US (24); PL (5); IT (2); FR (2); ME (3); BE (4); HU (5); CN (7); JP (9); UA (7); DE (1)