EpilepsyPhase 4NCT01546688
A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures
A Phase 4 study testing Zonisamide at targeted daily doses of 100-500 mg/day in people with Epilepsy, run by Eisai Limited at 36 sites in 7 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Zonisamide at targeted daily doses of 100-500 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 36 sitesin 7 countries
- Study dates
- Nov 2008to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Capable of maintaining a seizure daily diary or who have access to a caregiver who is prepared to complete this on the patient's behalf.
- Able to complete the questionnaires used in this study.
- Localization related epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the International League Against Epilepsy (ILAE) criteria.
- Have at least one well documented seizure in the 4 weeks preceding the Randomisation Visit (Visit 2) and are deemed to require additional AED medication.
- Receiving at least one, but not more than two other marketed AEDs as concomitant medication, and the dosage should be stable for at least four weeks before the Screening Visit.
Who cannot join
- Seizures attributed to metabolic causes (e.g., electrolyte disturbances, hyperglycaemia).
- Seizures which could be attributed to use of a drug.
- Presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
- A history of eating disorders or a body weight below 40 kg.
- A history of blood dyscrasias.
- A history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria.
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- An increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders.
- Taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis.
- Taking rifampicin or drugs with anticholinergic effects.
- Taking carbonic anhydrase inhibitors or topiramate.
- A history of pancreatitis.
- A history of Stevens Johnson Syndrome.
- Elevated levels of serum creatinine >165 Umol, or known severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
Hungary8 sites
Semmelweis University - Neurology Dept.
Budapest, 1083
Synexus Magyarorszag Kft.
Budapest, 11036
National Institute of Neurosurgery
Budapest, 1145
County Hospital Kecskemet
Keskemet, 6000
B-A-Z County Hospital - Szuleszet-Nogyogyaszat
Miskolc, 3501
Sopron Medical SMO
Sopron, 9400
County Hospital of Tolna
Szeksz?rd, 7100
County Hospital of Zala
Zalaegerszeg, 8900
Germany7 sites
Klinik und Polyklinik fur Epileptologie
Bonn
Georg-August-Universiat Gottingen
Göttingen
Asklepiosklinik Barmbek
Hamburg
Clinical Research Hamburg
Hamburg
ZNS Hamburg
Hamburg
Universitaet Giessen / Marburg
Marburg
Neurologische
Siegen
Italy7 sites
S.C. Neurologia - AO "G.Brotzu"
Cagliari, 00134
Dip. Di neuroscienze - Centro Epilessie - Osp. Careggi
Florence, 50134
Dipartimento di Neuroscienze - Universita Federico II
Naples, 80131
Centro Epilessia - Istituto Neurologico "Fondazione C. Mondino"
Pavia, 27100
Centro per la Diagnosi e Cura dell'epilessia - Policlinico Universitario di Messina
Pavia, 27100
Dip.to Scienze Neurologiche - III Clinica Neurologica
Roma, 00185
Universita di Torino - Dipt. Neuroscienze
Torino, 10126
Poland7 sites
Specjalistyczny Zaklad Opieki Zdrowotnej 'KONSYLIUM'
Kalisz, 62-800
Specjalistyczna Praktyka Lekarska
Katowice, 40- 097
NZOZ Centermed Gabinety ?lnolekarskie
Leszno, 64-100
Przych. Specj. I chorob Zaw. Wsi Instytut Medyc. Wsi im. W. Chodzki
Lublin, 20-090
Oddzia Neurologiczny, Wojewdzki Szpital Specjalistyczny
Olsztyn, 10-561
NZOZ Centrum Medyczne HCP
Późna, 61-489
Wielospecjalistyczna Lecznica 'Zycie'
Warsaw, 03-464
Switzerland3 sites
Clinical Investigation Unit; Inselspital
Bern, 3010
Spitalzentrum Biel
Biel, 2501
Epilepsie-Zentrum
Zurich, 8008
United Kingdom3 sites
Whipps Cross university Hospital
London, E11 1NR
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 7LN
The Royal Cornwall Hospital
Truro, TR1 3LJ
Netherlands1 site
Medisch Centrum Haaglanden - Lokatie Westeinde
VA Den Haag, 2512
About this study
Official title: A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures
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).
- Conditions
- Epilepsy
- Being tested
- Zonisamide at targeted daily doses of 100-500 mg/day, Placebo administered to match targeted daily doses of 100-500 mg/day
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zonisamide at targeted daily doses of 100-500 mg/dayDrug
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
Placebo administered to match targeted daily doses of 100-500 mg/dayDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide at targeted daily doses of 100-500 mg/day | Active comparator | Not described Receives: Drug: Zonisamide at targeted daily doses of 100-500 mg/day |
| Placebo administered to match daily doses of 100-500 mg/day | Placebo comparator | Not described Receives: Drug: Placebo administered to match targeted daily doses of 100-500 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Secondary outcomes (2)
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.
Measured: Baseline and Month 4
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.
Measured: Baseline and Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanna Segieth, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546688
- Sponsor's protocol ID
- E2090-E044-402
- Other IDs
- 2006-002516-10
- Status last verified
- Nov 2015
- First submitted
- 2 Mar 2012
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures
- ClinicalTrials.gov ID
- NCT01546688
- Acronym / sponsor ID
- E2090-E044-402
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 6 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zonisamide at targeted daily doses of 100-500 mg/day | Active comparator | Drug: Zonisamide at targeted daily doses of 100-500 mg/day |
| Placebo administered to match daily doses of 100-500 mg/day | Placebo comparator | Drug: Placebo administered to match targeted daily doses of 100-500 mg/day |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Capable of maintaining a seizure daily diary or who have access to a caregiver who is prepared to complete this on the patient's behalf.
- Able to complete the questionnaires used in this study.
- Localization related epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the International League Against Epilepsy (ILAE) criteria.
- Have at least one well documented seizure in the 4 weeks preceding the Randomisation Visit (Visit 2) and are deemed to require additional AED medication.
- Receiving at least one, but not more than two other marketed AEDs as concomitant medication, and the dosage should be stable for at least four weeks before the Screening Visit.
Key exclusion criteria (13 listed)
- Seizures attributed to metabolic causes (e.g., electrolyte disturbances, hyperglycaemia).
- Seizures which could be attributed to use of a drug.
- Presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
- A history of eating disorders or a body weight below 40 kg.
- A history of blood dyscrasias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonisamide at targeted daily doses of 100-500 mg/dayEach 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 | Drug | Zonisamide at targeted daily doses of 100-500 mg/day |
| Placebo administered to match targeted daily doses of 100-500 mg/daymatching placebo | Drug | Placebo administered to match daily doses of 100-500 mg/day |
Primary outcome
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
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.
Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.
2 secondary outcomes
Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period
Time frame: Baseline and Month 4
Percentage of Responders During Last 28 Days of Maintenance Period
Time frame: Baseline and Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Segieth study director
Eisai Limited
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zonisamide at targeted daily doses of 100-500 mg/day in people with Epilepsy, run by Eisai Limited at 36 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Hungary, Germany, Italy, Poland, Switzerland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period (time frame: Baseline, Week 4, Week 8, Week 12, Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.