Trial · NCT01954121
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
NCT01954121, Phase 3, Completed, UCB Pharma SA; results first posted 2016-08-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures. Trials, record NCT01954121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01954121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
- NCT number
- NCT01954121
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 436 participants, actual
- Lead sponsor
- UCB Pharma SA
- Conditions
- Epilepsy, Partial Seizures
- Interventions
- Levetiracetam, Carbamazepine
- First posted
- 2013-10-01
- Last updated
- 2017-08-15
- Results first posted
- 2016-08-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period | 6-months Evaluation Period (From Week 4 to Week 30) | |
| Secondary | Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period | From Week 1 to Week 30 | |
| Secondary | Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period | From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. |
| Secondary | Time to First Seizure During the Evaluation Period | From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. |
| Secondary | Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug | From Randomization (Week 1) up to Evaluation Visit (Week 30) | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period | 6-months Evaluation Period (From Week 4 to Week 30) | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period | From Week 1 to Week 30 | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | percentage of subjects | NUMBER |
| SECONDARY | Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period | From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | events | NUMBER |
| SECONDARY | Time to First Seizure During the Evaluation Period | From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | events | NUMBER |
| SECONDARY | Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug | From Randomization (Week 1) up to Evaluation Visit (Week 30) | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | events | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period | Levetiracetam (Per Protocol Set) | 47.3 | percentage of subjects | ||
| Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period | Carbamazepine-IR (Per Protocol Set) | 68.4 | percentage of subjects | ||
| Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period | Levetiracetam (Per Protocol Set) | 48.4 | percentage of subjects | ||
| Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period | Carbamazepine-IR (Per Protocol Set) | 70.2 | percentage of subjects | ||
| Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period | Levetiracetam (Per Protocol Set) | 88 | events | ||
| Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period | Carbamazepine-IR (Per Protocol Set) | 45 | events | ||
| Time to First Seizure During the Evaluation Period | Levetiracetam (Per Protocol Set) | 87 | events | ||
| Time to First Seizure During the Evaluation Period | Carbamazepine-IR (Per Protocol Set) | 39 | events | ||
| Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug | Levetiracetam (Per Protocol Set) | 97 | events | ||
| Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug | Carbamazepine-IR (Per Protocol Set) | 57 | events |
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 | Levetiracetam | 220 | |
| Overall Study | STARTED | Carbamazepine-IR | 216 | |
| Overall Study | COMPLETED | Levetiracetam | 93 | |
| Overall Study | COMPLETED | Carbamazepine-IR | 125 | |
| Overall Study | NOT COMPLETED | Levetiracetam | 127 | |
| Overall Study | NOT COMPLETED | Carbamazepine-IR | 91 |
Source ClinicalTrials.gov
Adverse events60
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 | Levetiracetam (Safety Set) | 40 | 218 | 48 |
| other | Nasopharyngitis | Infections and infestations | Carbamazepine-IR (Safety Set) | 32 | 215 | 42 |
| other | Upper respiratory tract infection | Infections and infestations | Levetiracetam (Safety Set) | 12 | 218 | 16 |
| other | Upper respiratory tract infection | Infections and infestations | Carbamazepine-IR (Safety Set) | 16 | 215 | 18 |
| other | Urinary tract infection | Infections and infestations | Levetiracetam (Safety Set) | 11 | 218 | 12 |
| other | Urinary tract infection | Infections and infestations | Carbamazepine-IR (Safety Set) | 5 | 215 | 5 |
| other | Blood cholesterol increased | Investigations | Levetiracetam (Safety Set) | 6 | 218 | 6 |
| other | Blood cholesterol increased | Investigations | Carbamazepine-IR (Safety Set) | 11 | 215 | 11 |
| other | Gamma-glutamyltransferase increased | Investigations | Levetiracetam (Safety Set) | 2 | 218 | 2 |
| other | Gamma-glutamyltransferase increased | Investigations | Carbamazepine-IR (Safety Set) | 11 | 215 | 11 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levetiracetam (Safety Set) | ||
| Total, all-cause mortality | Carbamazepine-IR (Safety Set) | ||
| Total, other adverse events | Levetiracetam (Safety Set) | 92 | 218 |
| Total, other adverse events | Carbamazepine-IR (Safety Set) | 93 | 215 |
| Total, serious adverse events | Levetiracetam (Safety Set) | 9 | 218 |
| Total, serious adverse events | Carbamazepine-IR (Safety Set) | 11 | 215 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Levetiracetam (Safety Set) vs Carbamazepine-IR (Safety Set): serious adverse events |
Source 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/NCT01954121
GET https://conductscience.org/api/trials/v1/NCT01954121/events?page=2