Trial · NCT02408523
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
NCT02408523, Phase 3, Completed, UCB BIOSCIENCES, Inc.; results first posted 2020-04-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications. Trials, record NCT02408523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02408523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
- NCT number
- NCT02408523
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 242 participants, actual
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Conditions
- Epilepsy
- Interventions
- Lacosamide Tablet, Lasosamide Oral Solution, Placebo Tablet, Placebo Oral Solution
- First posted
- 2015-04-03
- Last updated
- 2020-12-17
- Other registries' IDs
- eudract:2011-003100-21
- Results first posted
- 2020-04-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo. |
| Secondary | Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | A seizure-free day from primary generalized tonic clonic seizures (PGTCS) was defined as a day where no PGTCS were reported in the seizure diary and PGTCS were assessed, which was estimated using Kaplan-Meier (KM) methods. |
| Secondary | Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | The secondary efficacy variable was the time to the first primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of first PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to the number of events for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo. |
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator | From Visit 1 (Week -4) to End of Study Period (up to Week 36) | An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not related to the IMP. |
| Secondary | Plasma Concentrations of Lacosamide | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | Lacosamide plasma concentration was expressed in micrograms per milliliter (μg/mL). Means and standard deviation (SD) were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Values Below Limit of Quantification (BLQ) were replaced by value of 0 in calculations of means and SDs. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.~1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis. | events | NUMBER |
| SECONDARY | Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.~1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.~1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis. | events | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator | From Visit 1 (Week -4) to End of Study Period (up to Week 36) | The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo. | percentage of participants | NUMBER |
| SECONDARY | Plasma Concentrations of Lacosamide | During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo.~Data not collected from participants in Placebo (SS) Arm/Group. | ug/mL | MEAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | Placebo (FAS) | 76 | events | ||
| Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | Lacosamide (FAS) | 49 | events | ||
| Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | Placebo (FAS) | 17.3 | 95% Confidence Interval 10.3 to 24.3 | percentage of participants | |
| Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | Lacosamide (FAS) | 31.0 | 95% Confidence Interval 22.4 to 39.6 | percentage of participants | |
| Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | Placebo (FAS) | 97 | events | ||
| Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) | Lacosamide (FAS) | 79 | events | ||
| Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator | Placebo (SS) | 81.8 | percentage of participants | ||
| Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator | Lacosamide (SS) | 82.6 | percentage of participants | ||
| Plasma Concentrations of Lacosamide | Lacosamide (SS) | Visit 5, Week 6 (Titration) | 8.610961 | Standard Deviation 3.705438 | ug/mL |
| Plasma Concentrations of Lacosamide | Lacosamide (SS) | Visit 10, Week 24 (Maintenance) | 8.074427 | Standard Deviation 3.948749 | ug/mL |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 121 | |
| Overall Study | STARTED | Lacosamide | 121 | |
| Overall Study | Completed Treatment Period | Placebo | 110 | |
| Overall Study | Completed Treatment Period | Lacosamide | 103 | |
| Overall Study | Enrolled Transition Period | Placebo | 108 | |
| Overall Study | Enrolled Transition Period | Lacosamide | 101 | |
| Overall Study | Enrolled Taper Period | Placebo | 7 | |
| Overall Study | Enrolled Taper Period | Lacosamide | 9 | |
| Overall Study | Enrolled Safety Folllow-up Period | Placebo | 10 | |
| Overall Study | Enrolled Safety Folllow-up Period | Lacosamide | 11 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events264
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Placebo (SS) Treatment Period | 2 | 121 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Lacosamide (SS) Treatment Period | 8 | 121 | 8 |
| other | Vertigo | Ear and labyrinth disorders | Placebo (SS) Transition Period | 3 | 108 | 4 |
| other | Vertigo | Ear and labyrinth disorders | Lacosamide (SS) Transition Period | 1 | 101 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Placebo (SS) Taper Period | 0 | 7 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Lacosamide (SS) Taper Period | 0 | 9 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo (SS) Safety Follow-up Period | 0 | 10 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Lacosamide (SS) Safety Follow-up Period | 0 | 11 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo (SS) Treatment Period | 7 | 121 | 7 |
| other | Nausea | Gastrointestinal disorders | Lacosamide (SS) Treatment Period | 11 | 121 | 12 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (SS) Treatment Period | 0 | 121 |
| Total, all-cause mortality | Lacosamide (SS) Treatment Period | 0 | 121 |
| Total, all-cause mortality | Placebo (SS) Transition Period | 0 | 108 |
| Total, all-cause mortality | Lacosamide (SS) Transition Period | 0 | 101 |
| Total, all-cause mortality | Placebo (SS) Taper Period | 0 | 7 |
| Total, all-cause mortality | Lacosamide (SS) Taper Period | 0 | 9 |
| Total, all-cause mortality | Placebo (SS) Safety Follow-up Period | 0 | 10 |
| Total, all-cause mortality | Lacosamide (SS) Safety Follow-up Period | 0 | 11 |
| Total, other adverse events | Placebo (SS) Treatment Period | 41 | 121 |
| Total, other adverse events | Lacosamide (SS) Treatment Period | 60 | 121 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02408523
GET https://conductscience.org/api/trials/v1/NCT02408523/events?page=2