Trial · NCT01832038
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
NCT01832038, Phase 3, Completed, UCB Pharma SA; results first posted 2020-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures. Trials, record NCT01832038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01832038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
- NCT number
- NCT01832038
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 473 participants, actual
- Lead sponsor
- UCB Pharma SA
- Conditions
- Epilepsy, Partial-onset Seizures
- Interventions
- Lacosamide
- First posted
- 2013-04-15
- Last updated
- 2021-08-17
- Results first posted
- 2020-08-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit | From Visit 1 (Week 0) up to approximately Week 323 | 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. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Primary | Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit | From Visit 1 (Week 0) up to approximately Week 323 | 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 and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Secondary | Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 | The percent change from Baseline to the Treatment Period was calculated as {\[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)\] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\]. |
| Secondary | Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 | A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\]. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit | From Visit 1 (Week 0) up to approximately Week 323 | The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit | From Visit 1 (Week 0) up to approximately Week 323 | The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 | The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009. | Percent change | MEAN |
| SECONDARY | Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 | The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit | Lacosamide (SS) | 410 | Participants | ||
| Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit | Lacosamide (SS) | 51 | Participants | ||
| Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | Lacosamide (FAS) | -44.47 | Standard Deviation 55.82 | Percent change | |
| Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | Lacosamide (FAS) | 57.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lacosamide | 473 | |
| Overall Study | COMPLETED | Lacosamide | 238 | |
| Overall Study | NOT COMPLETED | Lacosamide | 235 |
Source ClinicalTrials.gov
Adverse events115
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 | Vision blurred | Eye disorders | Lacosamide (SS) | 22 | 473 | 29 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lacosamide (SS) | 28 | 473 | 57 |
| other | Diarrhoea | Gastrointestinal disorders | Lacosamide (SS) | 41 | 473 | 64 |
| other | Nausea | Gastrointestinal disorders | Lacosamide (SS) | 30 | 473 | 46 |
| other | Toothache | Gastrointestinal disorders | Lacosamide (SS) | 38 | 473 | 47 |
| other | Vomiting | Gastrointestinal disorders | Lacosamide (SS) | 37 | 473 | 66 |
| other | Pyrexia | General disorders | Lacosamide (SS) | 41 | 473 | 53 |
| other | Gastroenteritis | Infections and infestations | Lacosamide (SS) | 27 | 473 | 36 |
| other | Nasopharyngitis | Infections and infestations | Lacosamide (SS) | 156 | 473 | 510 |
| other | Pharyngitis | Infections and infestations | Lacosamide (SS) | 22 | 473 | 38 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide (SS) | 6 | 473 |
| Total, other adverse events | Lacosamide (SS) | 343 | 473 |
| Total, serious adverse events | Lacosamide (SS) | 83 | 473 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34246118 | RESULT |
Source PubMed
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/NCT01832038
GET https://conductscience.org/api/trials/v1/NCT01832038/events?page=2