Partial Onset SeizuresNCT01830868
A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)
An observational study of Partial Onset Seizures, run by Eisai Inc. at 37 sites in 5 countries.
Trial summary
This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive therapy prior to the decision to take part in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Onset Seizures
- What is being tested?
- Zonisamide tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 104 participants
- Where
- 37 sitesin 5 countries
- Study dates
- Mar 2012to Aug 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients With Partial Onset Seizures
Who may be able to join
- The decision to prescribe ZNS was made by the physician before and independently of his/her decision to include the patient in the study
- Patients treated with one drug licensed for the use as monotherapy in partial onset seizures
- Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive ZNS
- Patient was prescribed ZNS no longer than 2 weeks before baseline
- Treatment with ZNS has to be commenced in line with the drug's license and ZNS SmPC (Summary of Product Characteristics)
- Aged 18 years or older
- Capable of understanding the purpose of the study, fully informed and having given written informed consent.
Who cannot join
- Patients that have started ZNS outside the approved SmPC at enrolment
- Simultaneous participation in an interventional clinical trial and/or taking an investigational drug
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
Germany33 sites
Study site
Asperg
Study site
Baesweiler
Study site
Berlin
Study site
Bielefeld
Study site
Dortmund
Study site
Eisenach
Study site
Erbach im Odenwald
Study site
Erlangen
Study site
Fürth
Study site
Gladenbach
Study site
Hamburg
Study site
Haßfurt
Study site
Jülich
Study site
Kastellaun
Study site
Lage
Study site
Lappersdorf
Study site
Lauf
Study site
Lohr a. Main
Study site
Malchin
Study site
Mönchengladbach
Study site
München
Study site
Neuburg an der Donau
Study site
Neusäß
Study site
Osnabrück
Study site
Remscheid
Study site
Saarbrücken
Study site
Schorndorf
Study site
Schwäbisch Gmünd
Study site
Senftenberg
Study site
Stralsund
Study site
Stuttgart
Study site
Ulm
Study site
Velen
About this study
Official title: An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Observational Study of the Use of Zonisamide (ZNS) in the Adjunctive Treatment of Adult Patients With Partial Onset Seizures Treated With One Antiepileptic Drug (AED) as Baseline Medication
This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one dug licensed for the use of monotherapy in partial onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals which are appropriate to the typical practice of the treating clinician. Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.
Read the detailed description
Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study
- Conditions
- Partial Onset Seizures
- Being tested
- Zonisamide tablets
- Keywords
- ZNS, AED, Partial Onset Seizures, Retention Rate, Seizure Control, Antiepileptic, Secondary generalization, Seizure freedom rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zonisamide tabletsDrug
Also called ZNS
The recommended initial daily dose is 50 mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg. Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4 (cytochrome P450)-inducing agents, may respond to lower doses.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide tablets | Not described Receives: Drug: Zonisamide tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate of Zonisamide (ZNS) after 6 months from Baseline
The retention rate or the proportion of patients still receiving ZNS after 6 months will be assessed. At each of the two visits after 3 months and 6 months (final assessment or early discontinuation), the clinician will record whether the patient is still on ZNS treatment, or whether treatment has been discontinued.
Measured: Up to 6 months
Secondary outcomes (1)
Change in Seizure Frequency after 3 and 6 months from Baseline
Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ZNS.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Onset SeizuresStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hajo Hamer, Dr., Principal investigator, Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830868
- Sponsor's protocol ID
- E2090-E044-410
- Status last verified
- Feb 2018
- First submitted
- 10 Apr 2013
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Observational Study of the Use of Zonisamide (ZNS) in the Adjunctive Treatment of Adult Patients With Partial Onset Seizures Treated With One Antiepileptic Drug (AED) as Baseline Medication
- ClinicalTrials.gov ID
- NCT01830868
- Acronym / sponsor ID
- E2090-E044-410
- Conditions
- Partial Onset Seizures
- Keywords
- ZNS, AED, Partial Onset Seizures, Retention Rate, Seizure Control, Antiepileptic, Secondary generalization, Seizure freedom rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Apr 2013 (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.
This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one dug licensed for the use of monotherapy in partial onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals which are appropriate to the typical practice of the treating clinician. Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.
Detailed description
Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zonisamide tablets | – | Drug: Zonisamide tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients With Partial Onset Seizures
Key inclusion criteria (7 listed)
- The decision to prescribe ZNS was made by the physician before and independently of his/her decision to include the patient in the study
- Patients treated with one drug licensed for the use as monotherapy in partial onset seizures
- Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive ZNS
- Patient was prescribed ZNS no longer than 2 weeks before baseline
- Treatment with ZNS has to be commenced in line with the drug's license and ZNS SmPC (Summary of Product Characteristics)
Key exclusion criteria (3 listed)
- Patients that have started ZNS outside the approved SmPC at enrolment
- Simultaneous participation in an interventional clinical trial and/or taking an investigational drug
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.
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 tabletsAlso: ZNSThe recommended initial daily dose is 50 mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg. Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4 (cytochrome P450)-inducing agents, may respond to lower doses. | Drug | Zonisamide tablets |
Primary outcome
Retention Rate of Zonisamide (ZNS) after 6 months from Baseline
Time frame: Up to 6 months
The retention rate or the proportion of patients still receiving ZNS after 6 months will be assessed. At each of the two visits after 3 months and 6 months (final assessment or early discontinuation), the clinician will record whether the patient is still on ZNS treatment, or whether treatment has been discontinued.
1 secondary outcome
Change in Seizure Frequency after 3 and 6 months from Baseline
Time frame: Baseline, 3 months and 6 months
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 18 Jun 2023.
Related trials for Partial Onset Seizures
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures
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.
Hajo Hamer, Dr. principal investigator
Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Onset Seizures, run by Eisai Inc. at 37 sites in 5 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 7 inclusion and 3 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, Austria, Denmark, Norway, Sweden. 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.
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?
Retention Rate of Zonisamide (ZNS) after 6 months from Baseline (time frame: Up to 6 months). 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 18 Jun 2023.