Trial · NCT01118962
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
NCT01118962, Phase 2, Completed, UCB BIOSCIENCES, Inc.; results first posted 2013-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy. Trials, record NCT01118962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01118962
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
- NCT number
- NCT01118962
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Conditions
- Epilepsy
- Interventions
- Lacosamide
- First posted
- 2010-05-07
- Last updated
- 2018-07-17
- Other registries' IDs
- eudract:2014-004375-23
- Results first posted
- 2013-12-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) | |
| Primary | Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) |
Source ClinicalTrials.gov
Outcomes2
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 Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) | Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM). | participants | NUMBER |
| PRIMARY | Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) | Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
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 Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | Lacosamide | 37 | participants | ||
| Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | Lacosamide | 2 | 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 | 39 | |
| Overall Study | COMPLETED | Lacosamide | 29 | |
| Overall Study | NOT COMPLETED | Lacosamide | 10 |
Source ClinicalTrials.gov
Adverse events40
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 | PALPITATIONS | Cardiac disorders | Lacosamide | 2 | 39 | 2 |
| other | DIPLOPIA | Eye disorders | Lacosamide | 3 | 39 | 4 |
| other | NAUSEA | Gastrointestinal disorders | Lacosamide | 5 | 39 | 5 |
| other | DIARRHOEA | Gastrointestinal disorders | Lacosamide | 2 | 39 | 2 |
| other | FATIGUE | General disorders | Lacosamide | 3 | 39 | 4 |
| other | GAIT DISTURBANCE | General disorders | Lacosamide | 2 | 39 | 2 |
| other | SEASONAL ALLERGY | Immune system disorders | Lacosamide | 3 | 39 | 3 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Lacosamide | 10 | 39 | 13 |
| other | SINUSITIS | Infections and infestations | Lacosamide | 3 | 39 | 3 |
| other | GASTROENTERITIS VIRAL | Infections and infestations | Lacosamide | 2 | 39 | 3 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide | ||
| Total, other adverse events | Lacosamide | 35 | 39 |
| Total, serious adverse events | Lacosamide | 3 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28086164 | 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/NCT01118962
GET https://conductscience.org/api/trials/v1/NCT01118962/events?page=2