EpilepsyPhase 2NCT00938431

A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

A Phase 2 study testing Lacosamide in people with Epilepsy, run by UCB Pharma at 21 sites in 3 countries.

Completed

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

Trial summary

The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs). 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: 47 participants
Where: 21 sitesin 3 countries
Study dates: Nov 2009to Aug 2014
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

Subject is male or female between 1 month and 17 years of age inclusive
Subject's Body Mass Index (BMI) is within the 5th to 95th percentile for his/her age group
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 with at least 2 anti-epileptic 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

Who cannot join

Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device
Subject with seizures that are uncountable due to clustering during the 8-week period prior to study entry
Subject is on a ketogenic or other specialized diet
Subject has a history of primary generalized epilepsy
Subject has a history of status epilepticus within the 6-month period prior to Screening
Subject is receiving concomitant treatment with felbamate or has received previous felbamate therapy within the last 6 months prior to Screening

Show all 9Show fewer

Subject has taken or is currently taking vigabatrin
Subject is taking monoamine oxidase (MAO) inhibitors or narcotic analgesics
Subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months

Trial locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

United States14 sites

026
Austin, Texas
005
Durham, North Carolina
022
Houston, Texas
008
Kansas City, Missouri
004
Nashville, Tennessee
015
New Brunswick, New Jersey
020
Norfolk, Virginia
001
Philadelphia, Pennsylvania
016
Pittsburgh, Pennsylvania
025
Sacramento, California
006
Saint Paul, Minnesota
012
Tampa, Florida
002
Washington D.C., District of Columbia
019
Wellington, Florida

Other trials in United States

Mexico4 sites

101
Culiacán
104
Guadalajara
105
Monterrey
103
San Luis Potosí City

Other trials in Mexico

Belgium3 sites

201
Brussels
200
Edegem
202
Leuven

Other trials in Belgium

About this study

Official title: A Multicenter, Open-Label Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of Lacosamide (LCM) Oral Solution (Syrup) As Adjunctive Therapy In Children With Partial-Onset Seizures

Read the detailed description

Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.

Conditions: Epilepsy
Being tested: Lacosamide
Keywords: Lacosamide, Vimpat, Children, Epilepsy, Seizures, Anti-epileptic
Medical subject headings: Epilepsy, Seizures

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) 10 mg/mL or 15 mg/mL

Study groups in NCT00938431
Study group	Role	What they receive
Lacosamide - Age 5 - 11 years	Experimental	Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day Receives: Drug: Lacosamide
Lacosamide - (Age 12 - 17 years)	Experimental	Cohort 2 (Age 12 - 17 years); 12 mg/kg/day. Receives: Drug: Lacosamide
Lacosamide (Age 2 - 4 years)	Experimental	Cohort 3 (Age 2 - 4 years); 12 mg/kg/day. Receives: Drug: Lacosamide
Lacosamide (Age 5 - 11 years)	Experimental	Cohort 4 (Age 5 - 11 years); 12 mg/kg/day. Receives: Drug: Lacosamide
Lacosamide (Age 1 month - < 2 years)	Experimental	Cohort 5 (Age 1 month to < 2 years); 12 mg/kg/day Receives: Drug: Lacosamide

What is being measured

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

Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
Measured: 13 weeks

Secondary outcomes (11)

Change in Seizure Frequency From Baseline to End of Treatment
Measured: From Baseline to End of Treatment (approximately 13 weeks)
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status.
The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
1. Very much improved
2. Much improved
3. Minimally improved
4. No change
5. Minimally worse
6. Much worse
7. Very much worse
Measured: Visit 5 (Day 27/28) or Early Termination
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.
The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
1. Very much improved
2. Much improved
3. Minimally improved
4. No Change
5. Minimally worse
6. Much worse
7. Very much worse
Measured: Visit 5 (Day 27/28) or Early Termination
Plasma Ctrough Values for Lacosamide at Day 7
During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 7
Plasma Ctrough Values for Lacosamide at Day 28
During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 28
Plasma Ctrough Values for Lacosamide at Day 35
During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 35
Plasma Ctrough Values for Lacosamide at Day 42
During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 42
Plasma Ctrough Values for SPM 12809 at Day 7
SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 7
Plasma Ctrough Values for SPM 12809 at Day 28
SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 28
Plasma Ctrough Values for SPM 12809 at Day 35
SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 35
Plasma Ctrough Values for SPM 12809 at Day 42
SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Measured: Day 42

Timeline

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

Nov 2009Aug 2014

First posted13 Jul 2009 (estimated)
Study startNov 2009
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00938431
Sponsor's protocol ID: SP0847
Other IDs: 2011-001558-27
Status last verified: Jul 2017
First submitted: 2 Jul 2009
Last updated: 19 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

Publications

Winkler J, Schoemaker R, Stockis A. Population Pharmacokinetics of Adjunctive Lacosamide in Pediatric Patients With Epilepsy. J Clin Pharmacol. 2019 Apr;59(4):541-547. doi: 10.1002/jcph.1340. Epub 2018 Nov 14.
PubMed 30427550

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of Lacosamide (LCM) Oral Solution (Syrup) As Adjunctive Therapy In Children With Partial-Onset Seizures
ClinicalTrials.gov ID: NCT00938431
Acronym / sponsor ID: SP0847
Conditions: Epilepsy
Keywords: Lacosamide, Vimpat, Children, Epilepsy, Seizures, Anti-epileptic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 13 Jul 2009 (estimated)
Results: Posted 15 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Lacosamide - Age 5 - 11 years	Experimental	Drug: LacosamideCohort 1 (Age 5 - 11 years); up to 8 mg/kg/day
Lacosamide - (Age 12 - 17 years)	Experimental	Drug: LacosamideCohort 2 (Age 12 - 17 years); 12 mg/kg/day.
Lacosamide (Age 2 - 4 years)	Experimental	Drug: LacosamideCohort 3 (Age 2 - 4 years); 12 mg/kg/day.
Lacosamide (Age 5 - 11 years)	Experimental	Drug: LacosamideCohort 4 (Age 5 - 11 years); 12 mg/kg/day.
Lacosamide (Age 1 month - < 2 years)	Experimental	Drug: LacosamideCohort 5 (Age 1 month to < 2 years); 12 mg/kg/day

Who may qualify

Ages: 1 month to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Subject is male or female between 1 month and 17 years of age inclusive
Subject's Body Mass Index (BMI) is within the 5th to 95th percentile for his/her age group
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 with at least 2 anti-epileptic drugs (AEDs) (concurrently or sequentially)
Subject has been observed to have at least 2 countable seizures in the 4-week period prior to Screening

Key exclusion criteria (9 listed)

Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device
Subject with seizures that are uncountable due to clustering during the 8-week period prior to study entry
Subject is on a ketogenic or other specialized diet
Subject has a history of primary generalized epilepsy
Subject has a history of status epilepticus within the 6-month period prior to Screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LacosamideAlso: VimpatLacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL	Drug	Lacosamide (Age 1 month - < 2 years), Lacosamide (Age 2 - 4 years), Lacosamide (Age 5 - 11 years), Lacosamide - (Age 12 - 17 years), Lacosamide - Age 5 - 11 years

Primary outcome

Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
Time frame: 13 weeks

11 secondary outcomes

Change in Seizure Frequency From Baseline to End of Treatment
Time frame: From Baseline to End of Treatment (approximately 13 weeks)
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
Time frame: Visit 5 (Day 27/28) or Early Termination
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
Time frame: Visit 5 (Day 27/28) or Early Termination
Plasma Ctrough Values for Lacosamide at Day 7
Time frame: Day 7
Plasma Ctrough Values for Lacosamide at Day 28
Time frame: Day 28
Plasma Ctrough Values for Lacosamide at Day 35
Time frame: Day 35
Plasma Ctrough Values for Lacosamide at Day 42
Time frame: Day 42
Plasma Ctrough Values for SPM 12809 at Day 7
Time frame: Day 7
Plasma Ctrough Values for SPM 12809 at Day 28
Time frame: Day 28
Plasma Ctrough Values for SPM 12809 at Day 35
Time frame: Day 35
Plasma Ctrough Values for SPM 12809 at Day 42
Time frame: Day 42

Results and safety

Results posted to the registry on 15 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
>=1 Month to <4 Years (Safety Set)	15	9
>=4 Years to <12 Years (Safety Set)	23	14
>=12 Years to <=17 Years (Safety Set)	9	1

Primary outcome: Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)

Time frame: 13 weeks. Number. Unit: participants

Measure	>=1 Month to <4 Years (Safety Set) n = 15	>=4 Years to <12 Years (Safety Set) n = 23	>=12 Years to <=17 Years (Safety Set) n = 9
Value	14	19	9

Population analysed: The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
>=1 Month to <4 Years (Safety Set)	3 of 15 (20%)	11 of 15 (73.3%)	Not reported
>=4 Years to <12 Years (Safety Set)	3 of 23 (13%)	16 of 23 (69.6%)	Not reported
>=12 Years to <=17 Years (Safety Set)	0 of 9 (0%)	7 of 9 (77.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30427550Winkler J, Schoemaker R, Stockis A. Population Pharmacokinetics of Adjunctive Lacosamide in Pediatric Patients With Epilepsy. J Clin Pharmacol. 2019 Apr;59(4):541-547. doi: 10.1002/jcph.1340. Epub 2018 Nov 14.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Epilepsy

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

21 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lacosamide in people with Epilepsy, run by UCB Pharma at 21 sites in 3 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 6 inclusion and 9 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 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Mexico, Belgium. 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 15 Dec 2015). 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 Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) (time frame: 13 weeks). 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 NCT00938431, 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 19 Mar 2019.