Trial · NCT00477295
A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
NCT00477295, Phase 3, Completed, Eisai Inc.; results first posted 2013-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy. Trials, record NCT00477295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00477295
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
- NCT number
- NCT00477295
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 583 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Epilepsy
- Interventions
- Zonisamide, Carbamazepine
- First posted
- 2007-05-23
- Last updated
- 2015-12-24
- Other registries' IDs
- eudract:2006-000156-40
- Results first posted
- 2013-02-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase | Week 31 through Week 109 | A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. |
| Secondary | Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period | Week 5 through Week 109 | A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. |
| Secondary | Analysis of Time to Drop Out Due to an Adverse Event (AE) | Week 1 through Week 109 | An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline. |
| Secondary | Analysis of Time to Drop Out Due to Lack of Efficacy | Week 1 through Week 109 | Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy. |
| Secondary | Time to 6-months Seizure Freedom | Week 5 through Week 83 | A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. |
| Secondary | Time to 12-months Seizure Freedom | Week 5 through Week 83 | A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. |
| Secondary | Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems. |
| Secondary | Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line. Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria. |
| Secondary | Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales: 10 (Best possible quality of life) - 0 (Worst possible quality of life); Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales. |
| Secondary | Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase | Week 31 through Week 109 | Per Protocol Population: All randomized subjects who received at least one dose of study medication and who had no major protocol violations. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period | Week 5 through Week 109 | Per Protocol Population. N=number of subjects with evaluable data. | Percentage of participants | NUMBER |
| SECONDARY | Analysis of Time to Drop Out Due to an Adverse Event (AE) | Week 1 through Week 109 | Per Protocol Population | Median Days | MEDIAN |
| SECONDARY | Analysis of Time to Drop Out Due to Lack of Efficacy | Week 1 through Week 109 | Per Protocol Population | Median Days | MEDIAN |
| SECONDARY | Time to 6-months Seizure Freedom | Week 5 through Week 83 | Intent-to-Treat (ITT) Population - randomized subjects who received at least one dose of study medication. | Days | MEAN |
| SECONDARY | Time to 12-months Seizure Freedom | Week 5 through Week 83 | ITT Population | Days | MEAN |
| SECONDARY | Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication. This was measured using Observed Case (OC). | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | Intent-to-Treat Population. This was measured using Observed Case (OC). | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | Intent-to-Treat Population. This was measured using Observed Case (OC). | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1 | Baseline and Maintenance Period Visit 1 (Week 31 to Week 83) | Intent-to-Treat Population. This was measured using Observed Case (OC). | Scores on a Scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase | Zonisamide | 79.4 | Percentage of Participants | ||
| Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase | Carbamazepine | 83.7 | Percentage of Participants | ||
| Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period | Zonisamide | 67.6 | Percentage of participants | ||
| Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period | Carbamazepine | 74.7 | Percentage of participants | ||
| Analysis of Time to Drop Out Due to an Adverse Event (AE) | Zonisamide | NA | Standard Error NA | Median Days | |
| Analysis of Time to Drop Out Due to an Adverse Event (AE) | Carbamazepine | NA | Standard Error NA | Median Days | |
| Analysis of Time to Drop Out Due to Lack of Efficacy | Zonisamide | 722 | Standard Error NA | Median Days | |
| Analysis of Time to Drop Out Due to Lack of Efficacy | Carbamazepine | NA | Standard Error NA | Median Days | |
| Time to 6-months Seizure Freedom | Zonisamide | 222.7 | Standard Deviation 49.78 | Days | |
| Time to 6-months Seizure Freedom | Carbamazepine | 220.4 | Standard Deviation 46.31 | Days |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zonisamide | 282 | |
| Overall Study | STARTED | Carbamazepine | 301 | |
| Overall Study | COMPLETED | Zonisamide | 161 | |
| Overall Study | COMPLETED | Carbamazepine | 192 | |
| Overall Study | NOT COMPLETED | Zonisamide | 121 | |
| Overall Study | NOT COMPLETED | Carbamazepine | 109 |
Source ClinicalTrials.gov
Adverse events92
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 | headache | Nervous system disorders | Zonisamide | 29 | 281 | |
| other | headache | Nervous system disorders | Carbamazepine | 37 | 300 | |
| other | somnolence | Nervous system disorders | Zonisamide | 17 | 281 | |
| other | somnolence | Nervous system disorders | Carbamazepine | 23 | 300 | |
| other | dizziness | Nervous system disorders | Zonisamide | 11 | 281 | |
| other | dizziness | Nervous system disorders | Carbamazepine | 23 | 300 | |
| other | weight decreased | Investigations | Zonisamide | 19 | 281 | |
| other | weight decreased | Investigations | Carbamazepine | 0 | 300 | |
| other | decreased appetite | Metabolism and nutrition disorders | Zonisamide | 22 | 281 | |
| other | decreased appetite | Metabolism and nutrition disorders | Carbamazepine | 5 | 300 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 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 | 72 | 281 |
| Total, other adverse events | Carbamazepine | 69 | 300 |
| Total, serious adverse events | Zonisamide | 15 | 281 |
| Total, serious adverse events | Carbamazepine | 17 | 300 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22683226 | 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 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.
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