Trial · NCT01465997
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
NCT01465997, Phase 3, Completed, UCB BIOSCIENCES GmbH; results first posted 2017-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older. Trials, record NCT01465997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01465997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
- NCT number
- NCT01465997
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 551 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Epilepsy, Monotherapy
- Interventions
- Lacosamide, Carbamazepine-Controlled Release (CBZ-CR)
- First posted
- 2011-11-07
- Last updated
- 2018-07-18
- Other registries' IDs
- eudract:2010-021238-74
- Results first posted
- 2017-08-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) | Up to 3.5 Years (Duration of the Treatment Phase) | Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent. |
| Primary | Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) | Up to 3.5 Years (Duration of the Treatment Phase) | Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent. |
| Primary | Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) | Up to 3.5 Years (Duration of the Treatment Phase) | A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) | Up to 3.5 Years (Duration of the Treatment Phase) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) | Up to 3.5 Years (Duration of the Treatment Phase) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) | Up to 3.5 Years (Duration of the Treatment Phase) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) | Lacosamide (SS) | 181 | Participants | ||
| Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 182 | Participants | ||
| Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) | Lacosamide | 12 | Participants | ||
| Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) | Carbamazepine-Controlled Release (CBZ-CR) | 21 | Participants | ||
| Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) | Lacosamide | 32 | Participants | ||
| Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) | Carbamazepine-Controlled Release (CBZ-CR) | 22 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lacosamide | 279 | |
| Overall Study | STARTED | Carbamazepine-Controlled Release (CBZ-CR) | 269 | |
| Overall Study | COMPLETED | Lacosamide | 211 | |
| Overall Study | COMPLETED | Carbamazepine-Controlled Release (CBZ-CR) | 180 | |
| Overall Study | NOT COMPLETED | Lacosamide | 68 | |
| Overall Study | NOT COMPLETED | Carbamazepine-Controlled Release (CBZ-CR) | 89 |
Source ClinicalTrials.gov
Adverse events160
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 | Nasopharyngitis | Infections and infestations | Lacosamide (SS) | 20 | 279 | 40 |
| other | Nasopharyngitis | Infections and infestations | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 16 | 269 | 22 |
| other | Headache | Nervous system disorders | Lacosamide (SS) | 17 | 279 | 28 |
| other | Headache | Nervous system disorders | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 16 | 269 | 26 |
| other | Dizziness | Nervous system disorders | Lacosamide (SS) | 12 | 279 | 13 |
| other | Dizziness | Nervous system disorders | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 17 | 269 | 19 |
| serious | Eosinophilia | Blood and lymphatic system disorders | Lacosamide (SS) | 1 | 279 | 1 |
| serious | Eosinophilia | Blood and lymphatic system disorders | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 0 | 269 | 0 |
| serious | Angina pectoris | Cardiac disorders | Lacosamide (SS) | 2 | 279 | 2 |
| serious | Angina pectoris | Cardiac disorders | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 0 | 269 | 0 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide (SS) | ||
| Total, all-cause mortality | Carbamazepine-Controlled Release (CBZ-CR) (SS) | ||
| Total, other adverse events | Lacosamide (SS) | 45 | 279 |
| Total, other adverse events | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 42 | 269 |
| Total, serious adverse events | Lacosamide (SS) | 32 | 279 |
| Total, serious adverse events | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 22 | 269 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34265173 | DERIVED |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR): Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) | Trial comparisons |
| Lacosamide (SS) vs Carbamazepine-Controlled Release (CBZ-CR) (SS): Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) | Trial comparisons |
| Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR): Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) | Trial comparisons |
| Lacosamide (SS) vs Carbamazepine-Controlled Release (CBZ-CR) (SS): 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/NCT01465997
GET https://conductscience.org/api/trials/v1/NCT01465997/events?page=2