Trial · NCT01243177
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
NCT01243177, Phase 3, Completed, UCB BIOSCIENCES GmbH; results first posted 2016-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older. Trials, record NCT01243177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01243177
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
- NCT number
- NCT01243177
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 888 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Epilepsy, Monotherapy
- Interventions
- Lacosamide, Carbamazepine-Controlled Release
- First posted
- 2010-11-18
- Last updated
- 2021-02-02
- Other registries' IDs
- eudract:2010-019765-28
- Results first posted
- 2016-02-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject | The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods. |
| Primary | Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | 6 consecutive months (26 consecutive weeks) of treatment | The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods. |
| Primary | Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Duration of the Treatment Phase (up to 113 weeks) | An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can 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. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose. |
| Primary | Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Duration of the Treatment Phase (up to 113 weeks) | An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can 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. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose. |
| Primary | Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks) | Duration of the Treatment Phase (up to 113 weeks) | An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can 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. A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose. |
| Secondary | Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject | 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject | The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject | Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication. | percentage of subjects | NUMBER |
| PRIMARY | Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | 6 consecutive months (26 consecutive weeks) of treatment | The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy. | percentage of subjects | NUMBER |
| PRIMARY | Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Duration of the Treatment Phase (up to 113 weeks) | Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication. | Participants | NUMBER |
| PRIMARY | Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Duration of the Treatment Phase (up to 113 weeks) | Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication. | Participants | NUMBER |
| SECONDARY | Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject | 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject | Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication. | percentage of subjects | NUMBER |
| PRIMARY | Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks) | Duration of the Treatment Phase (up to 113 weeks) | Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | Lacosamide | 89.8 | 95% Confidence Interval 86.8 to 92.8 | percentage of subjects | |
Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | Carbamazepine-Controlled Release (CBZ-CR) | 91.1 | 95% Confidence Interval 88.2 to 94.0 | percentage of subjects | |
Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | Lacosamide | 91.4 | 95% Confidence Interval 88.5 to 94.3 | percentage of subjects | |
Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject | Carbamazepine-Controlled Release (CBZ-CR) | 92.8 | 95% Confidence Interval 90.1 to 95.6 | percentage of subjects | |
| Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Lacosamide | 328 | Participants | ||
| Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Carbamazepine-Controlled Release (CBZ-CR) | 332 | Participants | ||
| Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Lacosamide | 47 | Participants | ||
| Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Carbamazepine-Controlled Release (CBZ-CR) | 69 | Participants | ||
| Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject | Lacosamide | 77.8 | 95% Confidence Interval 73.4 to 82.2 | percentage of subjects | |
| Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject | Carbamazepine-Controlled Release (CBZ-CR) | 82.7 | 95% Confidence Interval 78.5 to 86.8 | percentage of subjects |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lacosamide | 444 | |
| Overall Study | STARTED | Carbamazepine-Controlled Release (CBZ-CR) | 442 | |
| Overall Study | COMPLETED | Lacosamide | 266 | |
| Overall Study | COMPLETED | Carbamazepine-Controlled Release (CBZ-CR) | 264 | |
| Overall Study | NOT COMPLETED | Lacosamide | 178 | |
| Overall Study | NOT COMPLETED | Carbamazepine-Controlled Release (CBZ-CR) | 178 |
Source ClinicalTrials.gov
Adverse events194
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 | Nausea | Gastrointestinal disorders | Lacosamide | 26 | 444 | 32 |
| other | Nausea | Gastrointestinal disorders | Carbamazepine-Controlled Release (CBZ-CR) | 23 | 442 | 30 |
| other | Fatigue | General disorders | Lacosamide | 34 | 444 | 38 |
| other | Fatigue | General disorders | Carbamazepine-Controlled Release (CBZ-CR) | 49 | 442 | 55 |
| other | Nasopharyngitis | Infections and infestations | Lacosamide | 29 | 444 | 42 |
| other | Nasopharyngitis | Infections and infestations | Carbamazepine-Controlled Release (CBZ-CR) | 29 | 442 | 37 |
| other | Gamma-glutamyltransferase increased | Investigations | Lacosamide | 7 | 444 | 8 |
| other | Gamma-glutamyltransferase increased | Investigations | Carbamazepine-Controlled Release (CBZ-CR) | 35 | 442 | 36 |
| other | Headache | Nervous system disorders | Lacosamide | 60 | 444 | 82 |
| other | Headache | Nervous system disorders | Carbamazepine-Controlled Release (CBZ-CR) | 58 | 442 | 78 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide | ||
| Total, all-cause mortality | Carbamazepine-Controlled Release (CBZ-CR) | ||
| Total, other adverse events | Lacosamide | 165 | 444 |
| Total, other adverse events | Carbamazepine-Controlled Release (CBZ-CR) | 181 | 442 |
| Total, serious adverse events | Lacosamide | 36 | 444 |
| Total, serious adverse events | Carbamazepine-Controlled Release (CBZ-CR) | 46 | 442 |
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 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 Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | Trial comparisons |
| Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR): Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) | 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 (up to 113 Weeks) | Trial comparisons |
| Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR): 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/NCT01243177
GET https://conductscience.org/api/trials/v1/NCT01243177/events?page=2