Trial · NCT01127256
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
NCT01127256, Phase 4, Completed, Eisai Korea Inc.; results first posted 2012-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation. Trials, record NCT01127256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01127256
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
- NCT number
- NCT01127256
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 200 participants, actual
- Lead sponsor
- Eisai Korea Inc.
- Conditions
- Epilepsy
- Interventions
- zonisamide, carbamazepine
- First posted
- 2010-05-20
- Last updated
- 2022-01-04
- Results first posted
- 2012-07-26
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants With Seizure Free Rate | 24 weeks | The percentage of participants who had no seizure during the trial. |
| Secondary | The Percentage of Participants With Retention Rate | 24 weeks | The percentage of participants who completed the trial. |
| Secondary | Quality of Life in Epilepsy (QoL-QOLIE31) | 24 weeks | Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life. |
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 | The Percentage of Participants With Seizure Free Rate | 24 weeks | percentage of participants | NUMBER | |
| SECONDARY | The Percentage of Participants With Retention Rate | 24 weeks | percentage of participants | NUMBER | |
| SECONDARY | Quality of Life in Epilepsy (QoL-QOLIE31) | 24 weeks | Units On a Scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants With Seizure Free Rate | Zonisamide | 73.7 | percentage of participants | ||
| The Percentage of Participants With Seizure Free Rate | Carbamazepine | 83.1 | percentage of participants | ||
| The Percentage of Participants With Retention Rate | Zonisamide | 59.4 | percentage of participants | ||
| The Percentage of Participants With Retention Rate | Carbamazepine | 62.5 | percentage of participants | ||
| Quality of Life in Epilepsy (QoL-QOLIE31) | Zonisamide | Pre-QOLIE 31 | 60.72 | Standard Deviation 14.69 | Units On a Scale |
| Quality of Life in Epilepsy (QoL-QOLIE31) | Carbamazepine | Pre-QOLIE 31 | 61.96 | Standard Deviation 16.67 | Units On a Scale |
| Quality of Life in Epilepsy (QoL-QOLIE31) | Zonisamide | Post-QOLIE 31 | 67.27 | Standard Deviation 16.34 | Units On a Scale |
| Quality of Life in Epilepsy (QoL-QOLIE31) | Carbamazepine | Post-QOLIE 31 | 69.51 | Standard Deviation 17.61 | Units On a Scale |
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 | Zonisamide | 96 | |
| Overall Study | STARTED | Carbamazepine | 104 | |
| Overall Study | COMPLETED | Zonisamide | 57 | |
| Overall Study | COMPLETED | Carbamazepine | 65 | |
| Overall Study | NOT COMPLETED | Zonisamide | 39 | |
| Overall Study | NOT COMPLETED | Carbamazepine | 39 |
Source ClinicalTrials.gov
Adverse events70
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 | Dizziness | Nervous system disorders | Zonisamide | 28 | 96 | 30 |
| other | Dizziness | Nervous system disorders | Carbamazepine | 23 | 104 | 24 |
| other | Drowsiness | Psychiatric disorders | Zonisamide | 25 | 96 | 25 |
| other | Drowsiness | Psychiatric disorders | Carbamazepine | 24 | 104 | 25 |
| other | Anorexia | Gastrointestinal disorders | Zonisamide | 20 | 96 | 21 |
| other | Anorexia | Gastrointestinal disorders | Carbamazepine | 5 | 104 | 5 |
| other | Weight Decrease | Investigations | Zonisamide | 16 | 96 | 17 |
| other | Weight Decrease | Investigations | Carbamazepine | 2 | 104 | 2 |
| other | Headache | Nervous system disorders | Zonisamide | 14 | 96 | 14 |
| other | Headache | Nervous system disorders | Carbamazepine | 14 | 104 | 14 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zonisamide | ||
| Total, all-cause mortality | Carbamazepine | ||
| Total, other adverse events | Zonisamide | 74 | 96 |
| Total, other adverse events | Carbamazepine | 70 | 104 |
| Total, serious adverse events | Zonisamide | 5 | 96 |
| Total, serious adverse events | Carbamazepine | 9 | 104 |
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 |
|---|
| Zonisamide vs Carbamazepine: 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/NCT01127256
GET https://conductscience.org/api/trials/v1/NCT01127256/events?page=2