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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002516-10 | EudraCT Number |
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A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zonisamide at targeted daily doses of 100-500 mg/day | Active Comparator |
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| Placebo administered to match daily doses of 100-500 mg/day | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zonisamide at targeted daily doses of 100-500 mg/day | Drug | Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period | The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST. | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period | The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation. | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period | Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. | Baseline and Month 4 |
| Percentage of Responders During Last 28 Days of Maintenance Period |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Segieth | Eisai Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Polyklinik fur Epileptologie | Bonn | Germany | ||||
| Georg-August-Universiat Gottingen |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects took matching doses of placebo during both the Titration Period and Maintenance Period. |
| FG001 | Zonisamide | Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo administered to match targeted daily doses of 100-500 mg/day | Drug | matching placebo |
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Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits. |
| Baseline and Month 4 |
| Göttingen |
| Germany |
| Asklepiosklinik Barmbek | Hamburg | Germany |
| Clinical Research Hamburg | Hamburg | Germany |
| ZNS Hamburg | Hamburg | Germany |
| Universitaet Giessen / Marburg | Marburg | Germany |
| Neurologische | Siegen | Germany |
| Semmelweis University - Neurology Dept. | Budapest | 1083 | Hungary |
| Synexus Magyarorszag Kft. | Budapest | 11036 | Hungary |
| National Institute of Neurosurgery | Budapest | 1145 | Hungary |
| County Hospital Kecskemet | Keskemet | 6000 | Hungary |
| B-A-Z County Hospital - Szuleszet-Nogyogyaszat | Miskolc | 3501 | Hungary |
| Sopron Medical SMO | Sopron | 9400 | Hungary |
| County Hospital of Tolna | Szeksz?rd | 7100 | Hungary |
| County Hospital of Zala | Zalaegerszeg | 8900 | Hungary |
| S.C. Neurologia - AO "G.Brotzu" | Cagliari | 00134 | Italy |
| Dip. Di neuroscienze - Centro Epilessie - Osp. Careggi | Florence | 50134 | Italy |
| Dipartimento di Neuroscienze - Universita Federico II | Naples | 80131 | Italy |
| Centro Epilessia - Istituto Neurologico "Fondazione C. Mondino" | Pavia | 27100 | Italy |
| Centro per la Diagnosi e Cura dell'epilessia - Policlinico Universitario di Messina | Pavia | 27100 | Italy |
| Dip.to Scienze Neurologiche - III Clinica Neurologica | Roma | 00185 | Italy |
| Universita di Torino - Dipt. Neuroscienze | Torino | 10126 | Italy |
| Medisch Centrum Haaglanden - Lokatie Westeinde | VA Den Haag | 2512 | Netherlands |
| Specjalistyczny Zaklad Opieki Zdrowotnej 'KONSYLIUM' | Kalisz | 62-800 | Poland |
| Specjalistyczna Praktyka Lekarska | Katowice | 40- 097 | Poland |
| NZOZ Centermed Gabinety ?lnolekarskie | Leszno | 64-100 | Poland |
| Przych. Specj. I chorob Zaw. Wsi Instytut Medyc. Wsi im. W. Chodzki | Lublin | 20-090 | Poland |
| Oddzia Neurologiczny, Wojewdzki Szpital Specjalistyczny | Olsztyn | 10-561 | Poland |
| NZOZ Centrum Medyczne HCP | Późna | 61-489 | Poland |
| Wielospecjalistyczna Lecznica 'Zycie' | Warsaw | 03-464 | Poland |
| Clinical Investigation Unit; Inselspital | Bern | 3010 | Switzerland |
| Spitalzentrum Biel | Biel | 2501 | Switzerland |
| Epilepsie-Zentrum | Zurich | 8008 | Switzerland |
| Whipps Cross university Hospital | London | E11 1NR | United Kingdom |
| University Hospital of North Staffordshire | Stoke-on-Trent | ST4 7LN | United Kingdom |
| The Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects took matching doses of placebo during both the Titration Period and Maintenance Period. |
| BG001 | Zonisamide | Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Population | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Safety Population: All randomized subjects who received at least one dose of study medication. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race. Safety Population. | Number | Participants |
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| Race/Ethnicity, Customized | Ethnicity. Safety Population. | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period | The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST. | Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication. | Posted | Mean | Standard Deviation | Seconds | Baseline, Week 4, Week 8, Week 12, Week 16 |
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| Primary | Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period | The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation. | Intent-to-Treat Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 4, Week 8, Week 12, Week 16 |
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| Secondary | Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period | Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. | Intent-to-Treat Population. | Posted | Median | Full Range | Percent Change | Baseline and Month 4 |
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| Secondary | Percentage of Responders During Last 28 Days of Maintenance Period | Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits. | Intent-to-Treat Population. Percentages are based on the number of subjects present in the Maintenance Phase. | Posted | Number | Percentage of Participants | Baseline and Month 4 |
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Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects took matching doses of placebo during both the Titration Period and Maintenance Period. | 1 | 18 | 8 | 18 | ||
| EG001 | Zonisamide | Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range. | 6 | 33 | 17 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA v.13.1 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA v.13.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA v.13.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA v.13.1 | Systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Sudden Death | General disorders | MedDRA v.13.1 | Systematic Assessment |
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| Vertebrobasilar insuffficiency | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA v.13.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v.13.1 | Systematic Assessment |
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| Asparatate aminotransferase increased | Investigations | MedDRA v.13.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v.13.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA v.13.1 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA v.13.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA v.13.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v.13.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA v.13.1 | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA v.13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v.13.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA v.13.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA v.13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v.13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v.13.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA v.13.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v.13.1 | Systematic Assessment |
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| Radicular syndrome | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v.13.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v.13.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA v.13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v.13.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v.13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Week 12 |
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| Week 16 |
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