Partial SeizuresPhase 4NCT01630057
Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug
A Phase 4 study testing Adjunctive Zonisamide and Replacement with Zonisamide in people with Partial Seizures, run by Eisai Inc. at 19 sites in Italy.
Trial summary
An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Partial Seizures
- What is being tested?
- Adjunctive Zonisamide and Replacement with Zonisamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 19 sitesItaly
- Study dates
- Sep 2009to Jul 2012
- 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
- Age ≥ 18 years;
- Patients with non progressive localization-related epilepsy;
- Patients who are able and willing to give written Informed Consent;
- Current treatment with three antiepileptic drugs. The last antiepileptic drug introduced must be zonisamide;
- 50% or greater seizure reduction* as assessed after an at least three-month maintenance period with zonisamide.
- = seizure frequency before starting zonisamide must be documented checking case histories.
Who cannot join
- Patients contraindicated for zonisamide use (see SmPC);
- Patients with renal or hepatic impairment;
- Pregnant or lactating women;
- Women of childbearing age who are not willing to use any contraceptive method with established efficacy.
- 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;
- Patients who have been on an investigational drug or device within 30 days prior to the initiation of the present study;
- Patients with a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the presence of a progressive neurological lesion within 12 months of the screening visit.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
AOU Ospedali riuniti Umberto I -G.M Lancisi-G.Salesi
Ancona, 60126
AO Universitaria Consorziale Policlinico di Bari
Bari, 70124
Irccs "E. Medea"
Bosisio Parini, 23842
Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari
Cagliari, 09124
IRCCS "Eugenio Medea" Polo Scientifico di Conegliano
Conegliano, 31015
AOU di Ferrara Arcispedale S. Anna
Ferrara, 44100
Presidio Ospedale "S.Antonio Abate di Gallarate"
Gallarate, 21013
UOC Neurofisiopatologia PO S. Salvatore
L’Aquila, Italy, 67100
AO della Provincia di Lodi
Lodi, 26900
IRCCS Centro neurolesi "Bonino Pulejo" di Messina
Messina, 98124
AO di Rilievo Nazionale Antonio Cardarelli
Naples, 80131
AO Universitaria Federico II
Naples, 80131
AO Universitaria Policlinico Paolo Giaccone dell'Universit? degli Studi di Palermo
Palermo, 90127
AO Universitaria -Pisana
Pisa, 56126
AO Regionale "San Carlo" di Potenza
Potenza, 85100
PO "Misericordia e dolce"-USL 4 di Prato
Prato, 59100
Azienda Complesso Ospedaliero San Filippo Neri
Roma, 00135
Umberto I Policlinico di Roma
Roma, 00161
Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana
Venezia, 30174
About this study
Official title: An Open-label, Randomized, Multi-centre, Superiority Study to Compare, in Patients With Partial Onset Seizures, the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug
An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide.
- Conditions
- Partial Seizures
- Being tested
- Adjunctive Zonisamide, Replacement with Zonisamide
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive ZonisamideDrug
Patients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events.
Replacement with ZonisamideDrug
Patients will continue to receive zonisamide as third drug
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive Zonisamide | Experimental | Patients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events. Receives: Drug: Adjunctive Zonisamide |
| Replacement with Zonisamide | Active comparator | Patients will continue to receive zonisamide as third drug Receives: Drug: Replacement with Zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Striano, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630057
- Sponsor's protocol ID
- E2090-E039-401
- Status last verified
- Jul 2014
- First submitted
- 16 Nov 2010
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-centre, Superiority Study to Compare, in Patients With Partial Onset Seizures, the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug
- ClinicalTrials.gov ID
- NCT01630057
- Acronym / sponsor ID
- E2090-E039-401
- Conditions
- Partial Seizures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Jun 2012 (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.
An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunctive Zonisamide | Experimental | Drug: Adjunctive ZonisamidePatients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events. |
| Replacement with Zonisamide | Active comparator | Drug: Replacement with ZonisamidePatients will continue to receive zonisamide as third drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Patients with non progressive localization-related epilepsy;
- Patients who are able and willing to give written Informed Consent;
- Current treatment with three antiepileptic drugs. The last antiepileptic drug introduced must be zonisamide;
- 50% or greater seizure reduction* as assessed after an at least three-month maintenance period with zonisamide.
Key exclusion criteria (8 listed)
- Patients contraindicated for zonisamide use (see SmPC);
- Patients with renal or hepatic impairment;
- Pregnant or lactating women;
- Women of childbearing age who are not willing to use any contraceptive method with established efficacy.
- Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation;
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 |
|---|---|---|
| Adjunctive ZonisamidePatients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events. | Drug | Adjunctive Zonisamide |
| Replacement with ZonisamidePatients will continue to receive zonisamide as third drug | Drug | Replacement with Zonisamide |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy
Time frame: 13 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 14 Jul 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.
Salvatore Striano principal investigator
Federico II University
19 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 Adjunctive Zonisamide and Replacement with Zonisamide in people with Partial Seizures, run by Eisai Inc. at 19 sites in Italy.
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 8 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy (time frame: 13 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 14 Jul 2014.