EpilepsyPhase 4NCT00165828
Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
A Phase 4 study testing Zonegran in people with Epilepsy, run by Eisai GmbH at 30 sites in Germany.
Trial summary
Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study, provided that they fulfill all inclusion criteria and none of the exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Zonegran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 30 sitesGermany
- Study dates
- May 2005to Feb 2008
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged between 18 years and 74 years
- Focal epileptic seizures with or without secondary generalization
- Present treatment with one or two antiepileptic drugs (constant dosage during 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
- For women of childbearing potential (postmenopausal for more than 1 year): possible pregnancy during the study can be excluded (by hysterectomy, sterilization or simultaneous application of two recognized methods of contraception (no oral contraceptives only)
- For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
- Written consent to participate in the study
- At least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 prospective or retrospective weeks baseline phase.
Who cannot join
- Epileptic state during the past year
- Non-epileptic fits
- Generalized epilepsy
- More than 4 weeks of seizure freedom during baseline phase
- Concomitant progressive CNS disease including progressive myoclonus epilepsy
- Concomitant treatment with vigabatrine and / or topiramate
Show all 23Show fewer
- Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)
- Body weight ≤ 40 kg
- (History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
- (History of) drug and/or alcohol dependence
- Active psychosis
- Suicide attempt during the past 3 years
- Pre-treatment with zonisamide
- Known hypersensitivity to sulfonamides
- concomitant treatment with neuroleptic drugs
- pregnant or breast feeding woman
- participation in another therapy study within 3 months prior to or during this study
- blood donation planned during or within 4 weeks after the participation in this study
- elective surgery planned during the participation in this study
- patient is not willing or not capable to meet the study demands
- patient does not agree to the forwarding of his/her pseudonymous data
- patient without legal competence
- More than 4 consecutive weeks of freedom from seizure during baseline phase
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Germany30 sites
Epilepsiezentrum Bethel/KSE
Beilefeld, 33617
Institut fur Diagnostik der Epilepsien Gmbh
Berlin, 10362
Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik
Berlin, 13353
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, 16321
St. Josephs Hospital, Neurologische Klinik
Bochum, 44791
Dr. Gunther Schumann
Bochum, 44805
Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik
Bochum, 44892
Universtitatsklinikum Bonn
Bonn, Nordrhein-Westphalen, 53105
Dr. Hans Martin Kolbinger
Bonn, 53127
Neuro-Consil Gmbh
Düsseldorf, 40212
Neurologische Klinik der Universitat Erlangen
Erlangen, 91054
Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie
Essen, 45147
Universitatsklinikum Freiburg, Neurozentrum
Freiburg im Breisgau, 79106
Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie
Göttingen, 37075
Gemeinschaftpraxis fur Neurologie und Psychiatrie
Hamburg, 22083
Dr. Heinrich C. Braeuer
Hamburg, 22299
Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf
Hamburg, 22337
Epilepsiezentrum Kork
Kehl, 77694
Epilepsiezentrum Kleinwachau, Epilepsieambulanz
Liegau-Augustusbad, 01465
Universitatsklinikum Mannheim, Neurologische Klinik, Ambulanz fur Anfallserkrankte
Mannheim, 68167
Universitatsklinikum, Interdisziplinares Epilepsiezentrum
Marburg, 35043
Klinikum Grosshadern, Neurologische Klinik und Poliklinik, Epilepsie-Ambulanz
München, 81377
Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Münster, Nordrhein-Westphalen, 48129
Klinikum Offenbach, Neurologie
Offenbach, 63069
Klinik Ernst von Bergmann
Potsdam, 14467
Universitat Regensburg, Klinik un Poliklinik fur Neurologie
Regensburg, 93053
Klinik "Die Weissenau", Anfallsambulanz
Revensburg, 88214
Universitat Rostock, Klinik fur Neurologie und Poliklinik
Rostock, 18147
Universitatsklinik Ulm Poliklinik fur Neurologie, Epilepsieambulanz
Ulm, 89075
Dr. Horst-Schmidt Klinik, Neurologie
Wiesbaden, 65199
About this study
Official title: Randomized Trial to Assess Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study, provided that they fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50 mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control assessments are performed at the beginning of the study and at the end of the prospective baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first, second, and third treatment week, and at the end of week six, the patient is additionally contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all control visits, and at the end of the study.
- Conditions
- Epilepsy
- Being tested
- Zonegran
- Keywords
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonegranDrug
Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zonegran |
| 2 | Experimental | Not described Receives: Drug: Zonegran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Elger, Principal investigator, Universitatsklinikum Bonn, Klinik fur Epileptologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165828
- Sponsor's protocol ID
- ZNS-D-04-001
- Other IDs
- 2005-000260-57, 2005
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 27 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Assess Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT00165828
- Acronym / sponsor ID
- ZNS-D-04-001
- Conditions
- Epilepsy
- Keywords
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Eisai GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 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.
Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study, provided that they fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50 mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control assessments are performed at the beginning of the study and at the end of the prospective baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first, second, and third treatment week, and at the end of week six, the patient is additionally contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all control visits, and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zonegran |
| 2 | Experimental | Drug: Zonegran |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult aged between 18 years and 74 years
- Focal epileptic seizures with or without secondary generalization
- Present treatment with one or two antiepileptic drugs (constant dosage during 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
- For women of childbearing potential (postmenopausal for more than 1 year): possible pregnancy during the study can be excluded (by hysterectomy, sterilization or simultaneous application of two recognized methods of contraception (no oral contraceptives only)
- For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
Key exclusion criteria (23 listed)
- Epileptic state during the past year
- Non-epileptic fits
- Generalized epilepsy
- More than 4 weeks of seizure freedom during baseline phase
- Concomitant progressive CNS disease including progressive myoclonus epilepsy
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 |
|---|---|---|
| ZonegranIntravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks. | Drug | 1, 2 |
Primary outcome
Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase.
Time frame: 28 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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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.
Christian Elger principal investigator
Universitatsklinikum Bonn, Klinik fur Epileptologie
30 sites in 1 country: 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 GmbH at 30 sites in Germany.
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 7 inclusion and 23 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany. 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 was stopped early. Results are not available in the source record.
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 in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase. (time frame: 28 days). 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 27 Jun 2014.