EpilepsyPhase 3NCT01964560
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
A Phase 3 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 141 sites in 35 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects. 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
- 540 participants
- Where
- 141 sitesin 35 countries
- Study dates
- 13 Aug 2014to 13 Apr 2022
- Phase
- Phase 3
- 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
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
- Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
- Subject is expected to benefit from participation, in the opinion of the investigator
- Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
- Subject is male or female aged 1 month to ≤17 years
- Subject has a diagnosis of epilepsy with partial-onset seizures
Who cannot join
- Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
- For subjects ≥6 years of age, subject 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 Visit 1
- Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception
Trial locations and contacts
141 sites in 35 countries.
141 sites in 35 countries
Russia16 sites
Ep0034 443
Kazan'
Ep0034 444
Kazan'
Ep0034 454
Kemerovo
Ep0034 442
Moscow
Ep0034 449
Moscow
Ep0034 456
Nizhny Novgorod
Ep0034 452
Novosibirsk
Ep0034 453
Omsk
Ep0034 455
Perm
Ep0034 441
Saint Petersburg
Ep0034 446
Saint Petersburg
Ep0034 440
Smolensk
Ep0034 730
Smolensk
Ep0034 458
Tomsk
Ep0034 447
Voronezh
Ep0034 450
Yekaterinburg
United States11 sites
Ep0034 638
Birmingham, Alabama, 35233-1711
Ep0034 102
Charlotte, North Carolina, 28203
Ep0034 129
Dallas, Texas, 75235
Ep0034 115
Henderson, Nevada, 89052
Ep0034 120
Lebanon, New Hampshire, 03756
Ep0034 124
Lexington, Kentucky, 40536-0284
Ep0034 105
Orlando, Florida, 32819
Ep0034 630
San Antonio, Texas, 78207
Ep0034 114
Seattle, Washington, 98105-0371
Ep0034 640
Springfield, Oregon, 97477
Ep0034 117
Tampa, Florida, 33609
Italy9 sites
Ep0034 397
Genova
Ep0034 380
Mantua
Ep0034 398
Messina
Ep0034 381
Milan
Ep0034 393
Padova
Ep0034 383
Roma
Ep0034 392
Roma
Ep0034 395
Roma
Ep0034 386
Verona
Poland9 sites
Ep0034 433
Gdansk
Ep0034 420
Kielce
Ep0034 422
Krakow
Ep0034 431
Krakow
Ep0034 423
Poznan
Ep0034 425
Poznan
Ep0034 429
Tyniec Mały
Ep0034 430
Warsaw
Ep0034 428
Wroclaw
Romania9 sites
Ep0034 574
Bucharest
Ep0034 581
Bucharest
Ep0034 572
Cluj-Napoca
Ep0034 582
Iași
Ep0034 573
Sibiu
Ep0034 576
Sibiu
Ep0034 580
Suceava
Ep0034 570
Timișoara
Ep0034 577
Timișoara
Hungary8 sites
Ep0034 361
Budapest
Ep0034 362
Budapest
Ep0034 363
Budapest
Ep0034 364
Budapest
Ep0034 368
Budapest
Ep0034 360
Debrecen
Ep0034 367
Miskolc
Ep0034 366
Pécs
Ukraine7 sites
Ep0034 602
Dnipro
Ep0034 609
Dnipro
Ep0034 681
Ivano-Frankivsk
Ep0034 600
Kiev
Ep0034 606
Kiev
Ep0034 682
Uzhhorod
Ep0034 603
Vinnytsia
China6 sites
Ep0034 530
Beijing
Ep0034 535
Changchun
Ep0034 532
Chongqing
Ep0034 536
Nanchang
Ep0034 531
Shanghai
Ep0034 537
Shenzhen
Mexico6 sites
Ep0034 694
Aguascalientes
Ep0034 569
Culiacán
Ep0034 693
Culiacán
Ep0034 563
Guadalajara
Ep0034 564
México
Ep0034 568
Monterrey
Thailand6 sites
Ep0034 236
Bangkoknoi
Ep0034 235
Pathum Wan
Ep0034 230
Ratchathewi
Ep0034 232
Ratchathewi
Ep0034 231
Tha Muang
Ep0034 233
Tha Muang
Serbia5 sites
Ep0034 461
Belgrade
Ep0034 464
Belgrade
Ep0034 460
Kragujevac
Ep0034 462
Novi Sad
Ep0034 463
Novi Sad
South Korea5 sites
Ep0034 211
Daegu
Ep0034 210
Seoul
Ep0034 212
Seoul
Ep0034 213
Seoul
Ep0034 215
Seoul
Czechia4 sites
Ep0034 321
Hradec Králové
Ep0034 320
Ostrava-poruba
Ep0034 323
Prague
Ep0034 322
Praha 4 - KRC
Georgia4 sites
Ep0034 620
Tbilisi
Ep0034 621
Tbilisi
Ep0034 622
Tbilisi
Ep0034 623
Tbilisi
Australia3 sites
Ep0034 200
Melbourne
Ep0034 203
Parkville
Ep0034 205
South Brisbane
Argentina2 sites
Ep0034 143
Ciudad Autonoma de Buenos AIRE
Ep0034 142
Córdoba
About this study
Official title: A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
- Conditions
- Epilepsy
- Being tested
- Lacosamide
- Keywords
- Lacosamide, Vimpat, UCB, Epilepsy, Partial-Onset Seizures, Pediatric
- 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
Pharmaceutical form: oral solution
Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)
Route of administration: oral use
LacosamideDrug
Also called VIMPAT
Pharmaceutical form: tablet
Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)
Route of administration: oral use
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | In the first week after enrollment into EP0034 subjects will be dosed according to their weight:
* Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing <30 kg
* LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to <50 kg
* LCM 300 mg/day (tablets) for subjects weighing ≥50 kg
After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets. Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Measured: From Week 0 to the End of Safety Follow-Up (up to Week 104)
Percentage of Participants With Serious TEAEs
A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Measured: From Week 0 to the End of Safety Follow-Up (up to Week 104)
Percentage of Participants With TEAEs Leading to Study Discontinuation
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Measured: From Week 0 to the End of Safety Follow-Up (up to Week 104)
Secondary outcomes (1)
Percentage of Seizure-free Days During the Study
The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.
Measured: From Week 0 to End of Treatment (up to Week 96)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start13 Aug 2014
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCB Biopharma SRL
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964560
- Sponsor's protocol ID
- EP0034
- Other IDs
- 2012-005012-26
- Status last verified
- Sep 2022
- First submitted
- 14 Oct 2013
- Last updated
- 25 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures
- ClinicalTrials.gov ID
- NCT01964560
- Acronym / sponsor ID
- EP0034
- Conditions
- Epilepsy
- Keywords
- Lacosamide, Vimpat, UCB, Epilepsy, Partial-Onset Seizures, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- UCB Biopharma SRL
- Study start
- 13 Aug 2014 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Posted 25 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: LacosamideIn the first week after enrollment into EP0034 subjects will be dosed according to their weight: * Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing <30 kg * LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to <50 kg * LCM 300 mg/day (tablets) for subjects weighing ≥50 kg After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
- Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
- Subject is expected to benefit from participation, in the opinion of the investigator
- Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
- Subject is male or female aged 1 month to ≤17 years
Key exclusion criteria (4 listed)
- Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
- For subjects ≥6 years of age, subject 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 Visit 1
- Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception
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: VIMPATPharmaceutical form: oral solution Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day) Route of administration: oral use | Drug | Lacosamide |
| LacosamideAlso: VIMPATPharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use | Drug | Lacosamide |
Primary outcome
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With Serious TEAEs
Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)
A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With TEAEs Leading to Study Discontinuation
Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
1 secondary outcome
Percentage of Seizure-free Days During the Study
Time frame: From Week 0 to End of Treatment (up to Week 96)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39216464Farkas 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.
- Product InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
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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 Cares study director
001 844 599 2273 (UCB)
141 sites in 35 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 141 sites in 35 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 4 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 141 sites in Russia, United States, Italy, Poland, Romania and 30 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Oct 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?
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)). 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 NCT01964560, 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 25 Oct 2022.