Trial · NCT01921205
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
NCT01921205, Phase 3, Completed, UCB Pharma; results first posted 2018-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures. Trials, record NCT01921205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01921205
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
- NCT number
- NCT01921205
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 404 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Epilepsy
- Interventions
- Lacosamide, Placebo
- First posted
- 2013-08-13
- Last updated
- 2018-07-18
- Other registries' IDs
- eudract:2012-004996-38
- Results first posted
- 2018-03-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period | Baseline to Week 16 (or last value on treatment) | The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. |
| Secondary | Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period | Baseline to Week 16 (or last value on treatment) | Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period. |
| Secondary | Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Baseline to Week 16 (or last value on treatment) | Proportion of subjects is presented as percentage of participants. A \>=25%-\<50% response in the Maintenance Period is defined as \>=25% to \<50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A \>=50%-\<=75% response in the Maintenance Period is defined as \>=50% to \<=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as \>75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. |
| Secondary | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. |
| Secondary | Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | Proportion of subjects is presented as percentage of participants. A \>=25%-\<50% response in the Treatment Period is defined as \>=25% to \<50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A \>=50%-\<=75% response in the Treatment Period is defined as \>=50% to \<=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as \>75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. |
| Secondary | Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | Proportion of subjects is presented as percentage of participants. No change is defined as between \<25% reduction and \<25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between \<25% reduction and \<25% increase is defined as a change. |
| Secondary | Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | Proportion of subjects is presented as percentage of participants. An increase is defined as a \>=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise \<25% increase is defined as no increase. |
| Secondary | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures | Baseline to Week 16 (or last value on treatment) | The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. |
| Secondary | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures | Baseline to Week 16 (or last value on treatment) | The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. |
| Secondary | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures | Baseline to Week 16 (or last value on treatment) | The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis. | Seizures per 28 days | MEDIAN |
| SECONDARY | Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. | percentage of participants | NUMBER |
| SECONDARY | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis. | Seizures per 28 days | MEDIAN |
| SECONDARY | Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Simple Partial Seizures were included in this analysis. | Seizures per 28 days | MEDIAN |
| SECONDARY | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Complex Partial Seizures were included in this analysis. | Seizures per 28 days | MEDIAN |
| SECONDARY | Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures | Baseline to Week 16 (or last value on treatment) | The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Secondary Generalized Seizures were included in this analysis. | Seizures per 28 days | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period | Placebo (FAS) | -1.55 | Full Range -318.7 to 690.0 | Seizures per 28 days | |
| Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period | Lacosamide (FAS) | -3.05 | Full Range -302.9 to 210.4 | Seizures per 28 days | |
| Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period | Placebo (FAS) | 33.3 | percentage of participants | ||
| Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period | Lacosamide (FAS) | 52.9 | percentage of participants | ||
| Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Placebo (FAS) | >=25% - <50% | 14.7 | percentage of participants | |
| Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Lacosamide (FAS) | >=25% - <50% | 11.8 | percentage of participants | |
| Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Placebo (FAS) | >=50% - <=75% | 17.1 | percentage of participants | |
| Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Lacosamide (FAS) | >=50% - <=75% | 21.8 | percentage of participants | |
| Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Placebo (FAS) | >75% | 15.9 | percentage of participants | |
| Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period | Lacosamide (FAS) | >75% | 31.2 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 172 | |
| Overall Study | STARTED | Lacosamide | 171 | |
| Overall Study | COMPLETED | Placebo | 151 | |
| Overall Study | COMPLETED | Lacosamide | 151 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Lacosamide | 20 |
Source ClinicalTrials.gov
Adverse events64
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 | Vomiting | Gastrointestinal disorders | Placebo | 11 | 172 | 15 |
| other | Vomiting | Gastrointestinal disorders | Lacosamide | 17 | 171 | 22 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 9 | 172 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | Lacosamide | 8 | 171 | 15 |
| other | Pyrexia | General disorders | Placebo | 10 | 172 | 11 |
| other | Pyrexia | General disorders | Lacosamide | 17 | 171 | 21 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 10 | 172 | 10 |
| other | Nasopharyngitis | Infections and infestations | Lacosamide | 20 | 171 | 29 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 10 | 172 | 14 |
| other | Upper respiratory tract infection | Infections and infestations | Lacosamide | 10 | 171 | 13 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 172 |
| Total, all-cause mortality | Lacosamide | 0 | 171 |
| Total, other adverse events | Placebo | 61 | 172 |
| Total, other adverse events | Lacosamide | 85 | 171 |
| Total, serious adverse events | Placebo | 13 | 172 |
| Total, serious adverse events | Lacosamide | 11 | 171 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lacosamide vs Placebo: deaths from any cause | Trial comparisons |
| Lacosamide vs Placebo: serious adverse events | Trial comparisons |
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/NCT01921205
GET https://conductscience.org/api/trials/v1/NCT01921205/results?page=2