EpilepsyPhase 4NCT00215592
Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
A Phase 4 study testing Zonegran in people with Epilepsy, run by Eisai Limited at 33 sites in 7 countries.
Trial summary
To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Zonegran
- How many people
- 1,000 participants
- Where
- 33 sitesin 7 countries
- Study dates
- Oct 2005to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-75.
- Able and willing to give written informed consent in accordance with the ICH GCP Guidelines.
- Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum βHCG at screening and negative urine pregnancy test at baseline/during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception as defined here is the oral contraceptive pill, surgical sterilization or hormonal intrauterine device in place for at least 3 months. Women who are less than 2 years post-menopausal are considered to be of childbearing potential.
- Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria.
- Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card.
- Patients should be receiving at least 1 but no more than 2 other AEDs as concomitant medication, and the dosage should be stable for at least 8 weeks before the baseline visit.
Who cannot join
- History of status epilepticus within the last 5 years.
- Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed. Note Investigators should consult included SmPC as a guide.
- Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation.
- Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
- Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease.
- Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides.
Show all 9Show fewer
- Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol.
- Any patient contraindicated for Zonegran treatment as per attached SmPC.
- Any patient who is pregnant and/or lactating.
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
France11 sites
Centre Hospitalier d'Annecy
Annecy, 74011
CH Germon et Gauthier
Béthune, 62408
Hopital Pellegrin Tripode
Bordeaux, 33076
Hopital Gabriel Montpied
Clermont-Ferrand, 63003
Hopital General
Dijon, 21033
Hopital Victor Jousselin
Dreux, 28102
Cabinet de neurologie
Gap, 05000
Hopital de la Timone Adultes
Marseille, 13385
Groupe hospitalier Pitie Salpetriere
Paris, 75651
Hopital de Font Pre
Toulon, 83056
CHU Bretonneau
Tours, 37044
Italy8 sites
Ospedale Riuniti di Bergamo
Bergamo, 24128
Azienda Ospedaliero- Universitaria Policlinico di Catania
Catania, 95125
Istituto Nazionale Neurologico Carlo Besta di Milano
Milan, 20133
Azienda Ospedaliera San Paolo
Milan, 20142
Universita di Parma
Parma, 43100
Azienda Ospedaliera Bianchi-Melancrino-Morelli
Reggio Calabria, 89100
Universita degli studi La Sapienza
Roma, 00161
Universita degli Studi La Sapienza
Roma, 00185
Germany6 sites
Universitatsklinikum Campus Virchow-Klinikum Wedding
Berlin, 13353
Epilepsieklinik Tabor
Bernau B. Berlin, 16321
Universitat Freiburg
Freiburg im Breisgau, 79106
Epilepsiezentrum Kork
Kehl-Kork, 77694
Arzneimittelforschung Leipzig GmbH
Leipzig, 04107
Klinik die Weissenau
Revensburg, 88214
Norway3 sites
Nevrologisk avdelning, 10 etasje
Lillehammer, 2609
Sandvika Neurologpraksis
Sandvika, 1338
Avd. for nevrologi og klinisk nevrofysiologi
Trondheim, 7006
Denmark2 sites
Danish Epilepsy Center
Dianalund, 4293
The Epilepsy Clinic
Glostrup Municipality, 2600
United Kingdom2 sites
University Hospital of Wales
Cardiff, CF14 4XW
University Hospital of North Staffordshire Royal Infirmary
Stoke-on-Trent, ST4 7LN
About this study
Official title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
- Conditions
- Epilepsy
- Being tested
- Zonegran
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonegranDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency, compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Tone Bjaaland, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215592
- Sponsor's protocol ID
- E2090-E044-401
- Other IDs
- 2005-001982-33, 2005
- Status last verified
- Nov 2015
- First submitted
- 14 Sep 2005
- Last updated
- 8 Jan 2016
- Results posted
- No
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
- An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
- ClinicalTrials.gov ID
- NCT00215592
- Acronym / sponsor ID
- E2090-E044-401
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18-75.
- Able and willing to give written informed consent in accordance with the ICH GCP Guidelines.
- Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum βHCG at screening and negative urine pregnancy test at baseline/during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception as defined here is the oral contraceptive pill, surgical sterilization or hormonal intrauterine device in place for at least 3 months. Women who are less than 2 years post-menopausal are considered to be of childbearing potential.
- Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria.
- Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card.
Key exclusion criteria (9 listed)
- History of status epilepticus within the last 5 years.
- Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed. Note Investigators should consult included SmPC as a guide.
- Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation.
- Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
- Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease.
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 |
|---|---|---|
| Zonegran | Drug | – |
Primary outcome
Seizure frequency, compared to baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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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.
Dr. Tone Bjaaland study director
Eisai Limited
33 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 Zonegran in people with Epilepsy, run by Eisai Limited at 33 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 6 inclusion and 9 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: finished, 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 33 sites in France, Italy, Germany, Norway, Denmark 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seizure frequency, compared to baseline.. 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.