A Phase 3 interventional study of Zonisamide and Carbamazepine in Epilepsy, sponsored by Eisai Inc.. Completed at 133 sites in 20 countries. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by Eisai Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 295 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Zonisamide
Drug: Carbamazepine
Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.
Also known as: Zonegran
Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.
Percentage of Participants Remaining in the Study at Each Visit
The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.
Time frame: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
Time to Drop-out Due to Lack of Efficacy
Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.
Time frame: Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)
Time to Drop-out Due to Adverse Event (AE)
Adverse events in study subjects included any change in the subject's condition. This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF).
Time frame: Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)
Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase
The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.
Time frame: Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)
Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.
Time frame: Weeks 0, 26, 52, 78 and 117
E2090-E044-314 is a double-blind extension of E2090-E044-310 (NCT00477295) "base study." Assessment of eligibility took place at the Study Entry Visit (SEV), which was the same day as their final visit of Study 310. Subjects remained on the same investigational product as they were randomized to in Study 310 until unblinding of that study.
| Milestone | Zonisamide | Carbamazepine |
|---|---|---|
| Started | 282 | 301 |
| Completed | 161 | 192 |
| Not completed | 121 | 109 |
| Withdrew: Adverse event | 31 | 35 |
| Withdrew: Withdrawal by subject | 35 | 24 |
| Withdrew: Lack of efficacy | 23 | 23 |
| Withdrew: Protocol violation | 3 | 8 |
| Withdrew: Physician decision | 4 | 5 |
| Withdrew: Lost to follow-up | 21 | 11 |
| Withdrew: Other | 4 | 3 |
| Milestone | Zonisamide | Carbamazepine |
|---|---|---|
| Started | 161 | 192 |
| Completed | 137 | 158 |
| Not completed | 24 | 34 |
| Withdrew: Chose not to enter 314 extension study | 24 | 34 |
| Milestone | Zonisamide | Carbamazepine |
|---|---|---|
| Started | 137 | 158 |
| Completed | 120 | 134 |
| Not completed | 17 | 24 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Withdrawal by subject | 8 | 12 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Other | 5 | 6 |
The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.
| Percentage of Participants | Zonisamide | Carbamazepine |
|---|---|---|
| 3 months | 95.6 (92.2 to 99.1) | 93.7 (89.8 to 97.5) |
| 6 months | 87.6 (82.0 to 93.2) | 84.2 (78.4 to 89.9) |
| 9 months | 76.6 (69.5 to 83.8) | 75.3 (68.5 to 82.1) |
| 12 months | 58.4 (50.1 to 66.7) | 61.4 (53.7 to 69.0) |
| 15 months | 38.7 (30.5 to 46.9) | 43.7 (35.9 to 51.5) |
| 18 months | 27.7 (20.2 to 35.3) | 27.8 (20.8 to 34.9) |
| 21 months | 13.1 (7.4 to 18.8) | 12.7 (7.4 to 17.9) |
| 24 months | 5.8 (1.9 to 9.8) | 2.5 (0.1 to 5.0) |
| 27 months | 1.5 (0.0 to 3.5) | 0.6 (0.0 to 1.9) |
Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.
| Days | Zonisamide | Carbamazepine |
|---|---|---|
| Time to Drop-out Due to Lack of Efficacy | 297.9 ± 170.03 | 289.0 ± 108.93 |
Adverse events in study subjects included any change in the subject's condition. This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF).
| Days | Zonisamide | Carbamazepine |
|---|---|---|
| Time to Drop-out Due to Adverse Event (AE) | 131.9 ± 166.90 | 97.2 ± 114.47 |
The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.
| Percentage of Participants | Zonisamide | Carbamazepine |
|---|---|---|
| Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase | 32.3 (26.5 to 38.0) | 35.2 (29.5 to 40.9) |
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.
| Score on a scale | Zonisamide | Carbamazepine |
|---|---|---|
| Week 0 | 4.697 ± 16.254 | 7.101 ± 13.781 |
| Week 26 | 6.101 ± 16.566 | 10.956 ± 14.940 |
| Week 52 | 8.602 ± 14.326 | 11.687 ± 13.653 |
| Week 78 | 4.287 ± 15.566 | 1.902 ± 13.495 |
| Week 117 | -0.292 ± 17.332 | 15.849 ± 12.302 |
Collected over From the time the subject signed the informed consent form through the Final Visit/Early Termination Visit and for 15 days following study drug discontinuation.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zonisamide (Extension Study 314, NCT00848549) | — | 7/137 (5.1%) | 12/137 (8.8%) |
| Carbamazepine (Extension Study 314, NCT00848549) | — | 7/158 (4.4%) | 10/158 (6.3%) |
| Zonisamide (Base Study 310, NCT00477295) | — | 15/281 (5.3%) | 72/281 (25.6%) |
| Carbamazepine (Base Study 310, NCT00477295) | — | 17/300 (5.7%) | 69/300 (23%) |
| Event | Zonisamide (Extension Study 314, NCT00848549) | Carbamazepine (Extension Study 314, NCT00848549) | Zonisamide (Base Study 310, NCT00477295) | Carbamazepine (Base Study 310, NCT00477295) |
|---|---|---|---|---|
| Partial seizures with secondary generalizationNervous system disorders | 0/137 | 0/158 | 0/281 | 4/300 |
| Abdominal painGastrointestinal disorders | 1/137 | 0/158 | 0/281 | 0/300 |
| Duodenal ulcer haemorrhageGastrointestinal disorders | 1/137 | 0/158 | 0/281 | 0/300 |
| Peptic ulcer haemorrhageGastrointestinal disorders | 1/137 | 0/158 | 0/281 | 0/300 |
| Carotid artery stenosisNervous system disorders | 1/137 | 0/158 | 0/281 | 0/300 |
| Transient ischaemic attackNervous system disorders | 1/137 | 0/158 | 0/281 | 0/300 |
| Myocardial ischaemiaCardiac disorders | 1/137 | 0/158 | 0/281 | 0/300 |
| Electrocardiogram abnormalInvestigations | 1/137 | 0/158 | 0/281 | 0/300 |
| Prostatic adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/137 | 0/158 | 0/281 | 0/300 |
| HypertensionVascular disorders | 1/137 | 0/158 | 0/281 | 0/300 |
| Event | Zonisamide (Extension Study 314, NCT00848549) | Carbamazepine (Extension Study 314, NCT00848549) | Zonisamide (Base Study 310, NCT00477295) | Carbamazepine (Base Study 310, NCT00477295) |
|---|---|---|---|---|
| HeadacheNervous system disorders | 6/137 | 10/158 | 29/281 | 37/300 |
| Decreased appetiteMetabolism and nutrition disorders | 0/137 | 0/158 | 22/281 | 5/300 |
| SomnolenceNervous system disorders | 0/137 | 0/158 | 17/281 | 23/300 |
| DizzinessNervous system disorders | 0/137 | 0/158 | 11/281 | 23/300 |
| Weight DecreasedInvestigations | 8/137 | 0/158 | 19/281 | 0/300 |
| Age, Continuous(years) | Zonisamide | Carbamazepine | Total |
|---|---|---|---|
| Base Study 310 (NCT00477295, n=583) | 37.1 ± 16.33 | 35.6 ± 15.50 | 36.35 ± 15.92 |
| Extension Study 314 (NCT00848549, n=295) | 37.8 ± 16.13 | 34.4 ± 14.93 | 36.1 ± 15.53 |
| Sex/Gender, Customized(participants) | Zonisamide | Carbamazepine | Total |
|---|---|---|---|
| Female (Base Study 310, NCT00477295) | 107 | 128 | 235 |
| Male (Base Study 310, NCT00477295) | 174 | 172 | 346 |
| Female (Extension Study 314, NCT00848549) | 57 | 59 | 116 |
| Male (Extension Study 314, NCT00848549) | 80 | 99 | 179 |
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The record gives a start of Oct 2008, a primary completion of Jun 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2013, 1 year 7 months after primary completion.
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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Zonisamide · Carbamazepine