A Phase 3 interventional study of Lacosamide in Epilepsy, sponsored by UCB Biopharma S.P.R.L.. Completed at 46 sites in 15 countries. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by UCB Biopharma S.P.R.L. (part of UCB S.A.) · Phase 3, Interventional, and Treatment
Among 37 studies testing lacosamide in Epilepsy — 1 open to participants now, 1 under way, none of them phase 3. Lacosamide · Epilepsy.
Among the 37 studies testing lacosamide in Epilepsy, this one is the 18th largest by enrollment, is the only one that started in 2016, is one of 24 in phase 3, and was the 30th registered.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 106 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →1 of the 37 studies testing lacosamide in Epilepsy is open now, in 1 country. Each count lists the studies.
Lacosamide: first FDA approval 2008 (VIMPAT), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →
Of the 285 Epilepsy studies recruiting now, 113 (40%) set no upper age limit and 149 (52%) stop at 75 or younger; 139 take children under 18; 56 take healthy volunteers.
This study: 17 Years and older · all sexes · no healthy volunteers.
The full table on the hub →37 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2016.
Median enrollment 103 across the 37 interventional studies. Of the 32 that completed or were terminated, 27 (84%) have results posted.
29 of 37 have an industry lead sponsor. The 10 most frequent:
UCB Biopharma S.P.R.L. is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
12 studies in Epilepsy by UCB Biopharma S.P.R.L.: none open now, none under way, none of them phase 3. Of 12 finished, 10 (83%) have results posted.
Among the 12 studies in Epilepsy by UCB Biopharma S.P.R.L., this one is the 4th largest by enrollment of the 11 interventional ones, is one of 2 that started in 2016, is one of 6 in phase 3, and was the 5th registered.
UCB Biopharma S.P.R.L.’s Epilepsy studies by the year they started, since 2011.
None of the studies under way reaches primary completion within a year.
Among the 37 studies testing lacosamide in Epilepsy, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among UCB Biopharma S.P.R.L.’s 12 in Epilepsy:
Nothing recorded among them since 2026-09-25.
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks.
Drug: Lacosamide
* Pharmaceutical Form: Oral tablets * Concentration: 50 mg * Route of Administration: Oral administration
Also known as: Vimpat, SPM927, LCM
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
The study started to enroll study participants in January 2016 and concluded in January 2020.
| Milestone | Lacosamide |
|---|---|
| Started | 106 |
| Completed | 84 |
| Not completed | 22 |
| Withdrew: Death | 1 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Investigator decision | 5 |
| Withdrew: Participant wants to get pregnant | 1 |
| Withdrew: Pregnancy | 2 |
| Withdrew: Sponsor decision | 1 |
| Withdrew: Withdrawal due to personal reasons | 1 |
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
| percentage of participants | Lacosamide (SS) |
|---|---|
| Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | 59.4 |
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
| percentage of participants | Lacosamide (SS) |
|---|---|
| Percentage of Participants That Withdrew Due to Adverse Events (AEs) | 0.9 |
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
| percentage of participants | Lacosamide (SS) |
|---|---|
| Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | 14.2 |
Collected over Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lacosamide (SS) | 1/106 (0.9%) | 15/106 (14.2%) | 19/106 (17.9%) |
| Event | Lacosamide (SS) |
|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/106 |
| EpilepsyNervous system disorders | 2/106 |
| Atrial FlutterCardiac disorders | 1/106 |
| Cardiac FailureCardiac disorders | 1/106 |
| Myocardial InfarctionCardiac disorders | 1/106 |
| Ventricular TachycardiaCardiac disorders | 1/106 |
| DiarrhoeaGastrointestinal disorders | 1/106 |
| Gastrooesophageal Reflux DiseaseGastrointestinal disorders | 1/106 |
| Umbilical HerniaGastrointestinal disorders | 1/106 |
| Device DislocationGeneral disorders | 1/106 |
| Event | Lacosamide (SS) |
|---|---|
| HeadacheNervous system disorders | 11/106 |
| NasopharyngitisInfections and infestations | 8/106 |
Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of study medication in SP1042.
| Age, Categorical(Participants) | Lacosamide |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 90 |
| >=65 years | 14 |
| Age, Continuous(years) | Lacosamide |
|---|---|
| Mean | 43.5 ± 17.1 |
| Sex: Female, Male(Participants) | Lacosamide |
|---|---|
| Female | 48 |
| Male | 58 |
| Race/Ethnicity, Customized(Participants) | Lacosamide |
|---|---|
| Asian | 19 |
| White | 86 |
| Other/Mixed | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lacosamide