A Phase 3 interventional study of Lacosamide and Lacosamide in Epilepsy, sponsored by UCB BIOSCIENCES, Inc.. Completed at 141 sites in 35 countries. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by UCB BIOSCIENCES, Inc. (part of UCB S.A.) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 540 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB BIOSCIENCES, Inc. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Lacosamide
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
Also known as: VIMPAT
Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use
Also known as: VIMPAT
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.
Time frame: 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.
Time frame: 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.
Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)
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.
Time frame: From Week 0 to End of Treatment (up to Week 96)
The study started to enroll participants in August 2014 and concluded in April 2022.
| Milestone | Lacosamide (All Subjects) |
|---|---|
| Started | 540 |
| Completed | 395 |
| Not completed | 145 |
| Withdrew: Adverse event | 23 |
| Withdrew: Lack of efficacy | 46 |
| Withdrew: Protocol deviation | 2 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 64 |
| Withdrew: Surgery-hemispherotomy | 1 |
| Withdrew: Surgery | 1 |
| Withdrew: Seizures appeared resolved with epilepsy surgery | 1 |
| Withdrew: Patient and investigator choice | 1 |
| Withdrew: Patient was prescribed cbd | 1 |
| Withdrew: Participant moved to another country | 1 |
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 | Lacosamide (All Subjects) |
|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 77.2 |
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 | Lacosamide (All Subjects) |
|---|---|
| Percentage of Participants With Serious TEAEs | 20.6 |
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.
| percentage of participants | Lacosamide (All Subjects) |
|---|---|
| Percentage of Participants With TEAEs Leading to Study Discontinuation | 4.1 |
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.
| percentage of seizure free days | Lacosamide (All Subjects) |
|---|---|
| Percentage of Seizure-free Days During the Study | 66.96 ± 36.18 |
Collected over From Week 0 to the End of Safety Follow-Up (up to Week 104). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lacosamide (All Subjects) | 7/540 (1.3%) | 111/540 (20.6%) | 289/540 (53.5%) |
| Event | Lacosamide (All Subjects) |
|---|---|
| ConvulsionNervous system disorders | 24/540 |
| PneumoniaInfections and infestations | 11/540 |
| VomitingGastrointestinal disorders | 10/540 |
| Status epilepticusNervous system disorders | 9/540 |
| EpilepsyNervous system disorders | 7/540 |
| BronchitisInfections and infestations | 5/540 |
| NauseaGastrointestinal disorders | 4/540 |
| PyrexiaGeneral disorders | 4/540 |
| Upper respiratory tract infectionInfections and infestations | 4/540 |
| Partial seizuresNervous system disorders | 4/540 |
| Event | Lacosamide (All Subjects) |
|---|---|
| PyrexiaGeneral disorders | 86/540 |
| Upper respiratory tract infectionInfections and infestations | 83/540 |
| NasopharyngitisInfections and infestations | 57/540 |
| VomitingGastrointestinal disorders | 56/540 |
| DiarrhoeaGastrointestinal disorders | 42/540 |
| PharyngitisInfections and infestations | 39/540 |
| CoughRespiratory, thoracic and mediastinal disorders | 38/540 |
| BronchitisInfections and infestations | 33/540 |
| SomnolenceNervous system disorders | 30/540 |
| HeadacheNervous system disorders | 29/540 |
Baseline Characteristics refer to the Safety Set which consisted of all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.
| Age, Continuous(years) | Lacosamide (All Subjects) |
|---|---|
| Mean | 7.486 ± 5.415 |
| Age, Customized(Participants) | Lacosamide (All Subjects) |
|---|---|
| >=28 days - <24 months | 103 |
| >=24 months - <12 years | 287 |
| >=12 - <18 years | 150 |
| Sex: Female, Male(Participants) | Lacosamide (All Subjects) |
|---|---|
| Female | 236 |
| Male | 304 |
| Race/Ethnicity, Customized(Participants) | Lacosamide (All Subjects) |
|---|---|
| American Indian/Alaskan native | 18 |
| Asian | 83 |
| Black | 4 |
| White | 414 |
| Other/mixed | 21 |
| Race/Ethnicity, Customized(Participants) | Lacosamide (All Subjects) |
|---|---|
| Hispanic or Latino | 68 |
| Not Hispanic or Latino | 472 |
Showing the first 100 of 141 sites across 35 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 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.
Access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, 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 pre-specified time, typically 12 months, on a password protected portal.
Data sharing details ↗ · www.vivli.org
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Studies of the drug tested here: Lacosamide