Trial · NCT01140867
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
NCT01140867, Phase 4, Completed, Eisai Korea Inc.; results first posted 2011-09-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy. Trials, record NCT01140867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01140867
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
- NCT number
- NCT01140867
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 121 participants, actual
- Lead sponsor
- Eisai Korea Inc.
- Conditions
- Epilepsy
- Interventions
- zonisamide
- First posted
- 2010-06-10
- Last updated
- 2022-01-04
- Results first posted
- 2011-09-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Seizure Reduction Rate | Baseline and 16 weeks | The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency. |
| Secondary | Seizure Free Rate | 16 weeks | The percentage of the participants who experienced no seizure during the trial. |
| Secondary | Responder Rate | Baseline and 16 weeks | The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%. |
| Secondary | QoL-QOLIE31 (Quality of Life in Epilepsy) | Baseline and 16 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
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Seizure Reduction Rate | Baseline and 16 weeks | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. | Percentage of Seizure Reduction Rate | MEAN |
| SECONDARY | Seizure Free Rate | 16 weeks | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. | Percentage of Participants | NUMBER |
| SECONDARY | Responder Rate | Baseline and 16 weeks | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. | Percentage of Participants | NUMBER |
| SECONDARY | QoL-QOLIE31 (Quality of Life in Epilepsy) | Baseline and 16 weeks | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included. | Units on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Seizure Reduction Rate | Zonisamide | -16.35 | Standard Deviation 436 | Percentage of Seizure Reduction Rate | |
| Seizure Free Rate | Zonisamide | 24.51 | Percentage of Participants | ||
| Responder Rate | Zonisamide | 61.76 | Percentage of Participants | ||
| QoL-QOLIE31 (Quality of Life in Epilepsy) | Zonisamide | Baseline- Pre-QOLIE 31 total score (N=90) | 56.67 | Standard Deviation 15.97 | Units on a Scale |
| QoL-QOLIE31 (Quality of Life in Epilepsy) | Zonisamide | 16 weeks - Post- QOLIE 31 total score (N=90) | 57.70 | Standard Deviation 15.74 | Units on a Scale |
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 | Zonisamide | 121 | |
| Overall Study | COMPLETED | Zonisamide | 88 | |
| Overall Study | NOT COMPLETED | Zonisamide | 33 |
Source ClinicalTrials.gov
Adverse events12
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 | 34 | 121 | 37 |
| other | Somnolence | Nervous system disorders | Zonisamide | 29 | 121 | 32 |
| other | Headache | Nervous system disorders | Zonisamide | 17 | 121 | 23 |
| other | Vomiting | Gastrointestinal disorders | Zonisamide | 16 | 121 | 16 |
| other | Anorexia | Metabolism and nutrition disorders | Zonisamide | 22 | 121 | 25 |
| other | Asthenia | General disorders | Zonisamide | 8 | 121 | 8 |
| other | Weight decreased | Investigations | Zonisamide | 13 | 121 | 13 |
| serious | Ligament rupture | Injury, poisoning and procedural complications | Zonisamide | 1 | 121 | 3 |
| serious | Brain contusion | Injury, poisoning and procedural complications | Zonisamide | 1 | 121 | 1 |
| serious | Rib fracture | Injury, poisoning and procedural complications | Zonisamide | 1 | 121 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zonisamide | ||
| Total, other adverse events | Zonisamide | 78 | 121 |
| Total, serious adverse events | Zonisamide | 2 | 121 |
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 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/NCT01140867
GET https://conductscience.org/api/trials/v1/NCT01140867/registered