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EpilepsyPhase 2NCT00938912

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

A Phase 2 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 69 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 month to 17 years
Conditions the study is for
Epilepsy
What is being tested?
Lacosamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
69 sitesin 11 countries
Study dates
9 Dec 2009to 18 May 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
  • Subjects who have participated in SP847 or other lacosamide (LCM) pediatric clinical studies in epilepsy must fulfill the following inclusion criteria:
  • 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
  • Subjects who enroll directly into SP848 without previous participation in a LCM clinical study must fulfill the following inclusion criteria:
Show all 12Show fewer
  • 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

Who cannot join

  • 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)
Show all 25Show fewer
  • 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

Trial locations and contacts

69 sites in 11 countries.

69 sites in 11 countries

United States24 sites

  • Sp848 053

    Akron, Ohio, 44308

  • Sp848 057

    Augusta, Georgia, 30912-4005

  • Sp848 026

    Austin, Texas, 78723

  • Sp848 064

    Birmingham, Alabama, 35233

  • Sp848 068

    Cincinnati, Ohio, 45229

  • Sp848 067

    Dallas, Texas, 75235

  • Sp848 005

    Durham, North Carolina, 27710

  • Sp848 062

    Hackensack, New Jersey, 07601

  • Sp848 022

    Houston, Texas, 77076

  • Sp848 008

    Kansas City, Missouri, 64108

  • Sp848 061

    Las Vegas, Nevada, 89052

  • Sp848 059

    Los Angeles, California, 90027-6062

  • Sp848 004

    Nashville, Tennessee, 37212

  • Sp848 015

    New Brunswick, New Jersey, 08901

  • Sp848 020

    Norfolk, Virginia, 23510

  • Sp848 054

    Orlando, Florida, 32819

  • Sp848 001

    Philadelphia, Pennsylvania, 19104

  • Sp848 016

    Pittsburgh, Pennsylvania, 15201

  • Sp848 025

    Sacramento, California, 95815

  • Sp848 063

    Saint Paul, Minnesota, 55101

  • Sp848 006

    Saint Paul, Minnesota, 55102

  • Sp848 012

    Tampa, Florida, 33609

  • Sp848 002

    Washington D.C., District of Columbia, 20010

  • Sp848 019

    Wellington, Florida, 33470

Other trials in United States

Japan9 sites

  • Sp848 257

    Fukuoka

  • Sp848 256

    Hamamatsu

  • Sp848 255

    Kodaira

  • Sp848 253

    Kōshi

  • Sp848 252

    Niigata

  • Sp848 258

    Okayama

  • Sp848 254

    Osaka

  • Sp848 259

    Osaka

  • Sp848 251

    Shizuoka

Other trials in Japan

China7 sites

  • Sp848 950

    Beijing

  • Sp848 953

    Changchun

  • Sp848 951

    Chongqing

  • Sp848 955

    Hanzhou

  • Sp848 956

    Nanchang

  • Sp848 952

    Shanghai

  • Sp848 954

    Shenzhen

Other trials in China

Ukraine7 sites

  • Sp848 224

    Dnipro

  • Sp848 225

    Dnipro

  • Sp848 220

    Ivano-Frankivsk

  • Sp848 221

    Kiev

  • Sp848 222

    Kiev

  • Sp848 226

    Kiev

  • Sp848 223

    Vinnytsia

Other trials in Ukraine

Hungary5 sites

  • Sp848 701

    Budapest

  • Sp848 702

    Budapest

  • Sp848 703

    Budapest

  • Sp848 704

    Budapest

  • Sp848 705

    Debrecen

Other trials in Hungary

Poland5 sites

  • Sp848 803

    Bialystok

  • Sp848 807

    Katowice

  • Sp848 804

    Kielce

  • Sp848 801

    Krakow

  • Sp848 805

    Lublin

Other trials in Poland

Belgium4 sites

  • Sp848 201

    Brussels

  • Sp848 200

    Edegem

  • Sp848 203

    Ghent

  • Sp848 202

    Leuven

Other trials in Belgium

Mexico3 sites

  • Sp848 101

    Culiacán

  • Sp848 104

    Guadalajara

  • Sp848 103

    San Luis Potosí City

Other trials in Mexico

France2 sites

  • Sp848 309

    Paris

  • Sp848 304

    Strasbourg

Other trials in France

Italy2 sites

  • Sp848 503

    Messina

  • Sp848 502

    Verona

Other trials in Italy

Germany1 site

  • Sp848 403

    Kork

Other trials in Germany

About this study

Official title: An Open-Label Study To Determine Safety, Tolerability And Efficacy Of Long -Term Oral Lacosamide (LCM) As Adjunctive Therapy In Children With Epilepsy

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.

Read the 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
Being tested
Lacosamide
Keywords
Lacosamide (VIMPAT)
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LacosamideDrug

    Also called Vimpat®

    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)

  • LacosamideDrug

    Also called Vimpat®

    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.

Study groups in NCT00938912
Study groupRoleWhat they receive
LacosamideExperimentalSubjects 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.
Receives: Drug: Lacosamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (5)

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

    Percent change in seizure frequency per 28 days (PCH) from the Baseline value (B) to Treatment Period interval (T) was defined as:PCH = [(SFT - SFB)/SFB] x 100 where, SFT corresponded to seizure frequency during Treatment Period for relative interval in open-label study and SFB corresponded to Baseline seizure frequency. For both periods, the frequency was standardized to the number of seizures per 28 days. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count case report form/electronic case report form (CRF/eCRF) module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.

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

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

    A 50% responder is a participant experiencing a ≥50% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.

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

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

    A 75% responder is a participant experiencing a ≥75% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.

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

  4. Number of Seizure Days Per 28 Days for Participants With Generalized Seizures

    A seizure day was defined as a day where any type of seizure was reported in the seizure diary and seizures were assessed. Days in the seizure diary which were marked as "not done" on the CRF/eCRF were not counted as seizure-free days.

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

  5. Percentage of Participants Who Achieved a Seizure-free Status

    Study participants were considered seizure-free for a given period if they completed the period, reported zero seizures during the period, and had no more than 10% of days in the period for which seizure data were not available (ie, "not done" was noted on the Seizure Frequency CRF/eCRF module).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2009 (estimated)
  2. Study start9 Dec 2009
  3. Primary completion18 May 2021
  4. Study completion18 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00938912
Sponsor's protocol ID
SP848
Other IDs
2011-001559-35
Status last verified
Dec 2021
First submitted
10 Jul 2009
Last updated
18 Jan 2022
Data monitoring committee
No
Expanded access
Available

Publications

  • Farkas MK, Makedonska I, Beller C, Bourikas D, de la Loge C, Dimova S, Floricel F, McClung C, Moseley B, Therriault S, Pina-Garza JE. Long-term efficacy, safety, and tolerability, including behavior and executive functioning, during adjunctive lacosamide treatment in pediatric patients with uncontrolled epilepsy. Epilepsy Behav. 2024 Oct;159:109989. doi: 10.1016/j.yebeh.2024.109989. Epub 2024 Aug 30.

    PubMed 39216464

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 69 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Japan, China, Ukraine, Hungary and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) (time frame: From Baseline to End of Safety Follow-Up (up to 4.3 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00938912, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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Clinical Trial NCT00938912 | AzTrials