Partial SeizuresPhase 3NCT01136954
A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
A Phase 3 study testing Zonisamide in people with Partial Seizures, run by Eisai Limited at 1 site in Italy.
Trial summary
The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Partial Seizures
- What is being tested?
- Zonisamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to Mar 2012
- Phase
- Phase 3
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject has completed the double-blind study E2090-E044-312.
- Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent.
- Subject is male or female aged 6 to 18 years who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent.
- Subject is in general good health as determined by medical history, physical exam and screening laboratory results.
Who cannot join
- Subject has a body weight < 20 kg.
- Subject has developed a history of renal calculi or renal insufficiency (creatinine level > 135 µmol/l (1.5 mg/dl).
- Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
- Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its excipients.
- Female subject of 10 years of age or greater, or of child bearing potential (i.e. started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e. oral contraceptive pill, surgical sterilization, an implant or injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication. NOTE: Should a female subject become of child bearing potential during the study, they must be reconsented in order to given consent to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception.
- Subject has a recent history of excessive alcohol use or drug abuse.
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- Subject has a history of suicide attempt.
- Subject has a clinically significant organic disease.
- Subject has a history of demonstrated non-compliance with treatment or subject or parent/legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study.
- Frequent need of rescue benzodiazepines (one or more times a month).
- Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity.
- Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Extension Study Following a Double-blind, Randomized, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Pediatric Partial Onset Seizures
The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).
Read the detailed description
Those subjects who completed the double-blind study (E2090-E044-312) will be invited to participate in this extension study. The study consists of two main parts: Transition Period (double-blind) and Open Label Period. The study will start with the Transition Period during which subjects already on zonisamide will continue on the same dose of zonisamide and those who were taking placebo will be up-titrated to an appropriate dose of zonisamide. After all subjects have completed the Transition Period, the study will become open-label with every subject on the study receiving zonisamide. The study medication will be taken once daily in the evening. For those subjects previously in the placebo group, dosing with zonisamide will start with a dose of approximately 1 mg/kg. In order that the blind is maintained from the previous study, these subjects will initially continue taking the same number of placebo capsules as they were taking in the Maintenance Period of the E2090-E044-312 study until the up- titration is completed. Those subjects previously in the zonisamide arm will continue on the same dose which they received during the Maintenance Period of the E2090-E044-312 study. In order that the blind is maintained, they will also take placebo capsules in order to mirror the up- titration dose regimen of the subjects previously randomized to receive placebo in the E2090-E044-312 study. All subjects will stop taking placebo capsules after the Transition Period is complete. The duration of the Transition Period depends on the dose the subject appeared to have received when completing the core study E2090-E044-312. For those who completed on 8 mg/kg, the Transition Period will last 7 weeks. For those on 6 mg/kg, the Transition Period will last 5 weeks. However, during the double-blind Transition Period, some subjects may experience adverse events (AEs). If this should occur, the subject may be down titrated to one level above the minimal dose. The overall duration of the study will be up to 59 weeks. The overall duration of the Transition Period may thus be as short as 2 weeks or prolonged to as many as 11 weeks.
The Open Label Period will continue for up to a maximum of 59 weeks (approximately 15 months).
At the end of the study, Eisai will continue to supply zonisamide as part of this open-label extension protocol until the marketing authorisation of zonisamide for this indication or further development in this indication is stopped. In countries where no marketing authorisation will be applied for, Eisai has a compassionate use policy which can be applied for, if required.
- Conditions
- Partial Seizures
- Being tested
- Zonisamide
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
Also called Zonegran
Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.
Measured: Week 1 through Week 59
Secondary outcomes (3)
Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period
A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants'parent or guardian maintained a seizure diary recording the date,number, and type of seizures the subject had. The primary analysis assessed the percent of responders from baseline in the Open Label Visit Period. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.
Measured: Baseline through Week 59
Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period
Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period.
Measured: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313
Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period
Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period. Percentage change = 100% x (seizure frequency at period - seizure frequency at Study 312 baseline)/seizure frequency at Study 312 baseline.
Measured: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionJan 2012
- Study completionMar 2012
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 Partial SeizuresStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rob van Maanen, M.D., MFPM, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136954
- Sponsor's protocol ID
- E2090-E044-313
- Other IDs
- 2007-000198-53
- Status last verified
- Nov 2015
- First submitted
- 26 May 2010
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study Following a Double-blind, Randomized, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Pediatric Partial Onset Seizures
- ClinicalTrials.gov ID
- NCT01136954
- Acronym / sponsor ID
- E2090-E044-313
- Conditions
- Partial Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Jun 2010 (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.
The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).
Detailed description
Those subjects who completed the double-blind study (E2090-E044-312) will be invited to participate in this extension study. The study consists of two main parts: Transition Period (double-blind) and Open Label Period. The study will start with the Transition Period during which subjects already on zonisamide will continue on the same dose of zonisamide and those who were taking placebo will be up-titrated to an appropriate dose of zonisamide. After all subjects have completed the Transition Period, the study will become open-label with every subject on the study receiving zonisamide. The study medication will be taken once daily in the evening. For those subjects previously in the placebo group, dosing with zonisamide will start with a dose of approximately 1 mg/kg. In order that the blind is maintained from the previous study, these subjects will initially continue taking the same number of placebo capsules as they were taking in the Maintenance Period of the E2090-E044-312 study until the up- titration is completed. Those subjects previously in the zonisamide arm will continue on the same dose which they received during the Maintenance Period of the E2090-E044-312 study. In order that the blind is maintained, they will also take placebo capsules in order to mirror the up- titration dose regimen of the subjects previously randomized to receive placebo in the E2090-E044-312 study. All subjects will stop taking placebo capsules after the Transition Period is complete. The duration of the Transition Period depends on the dose the subject appeared to have received when completing the core study E2090-E044-312. For those who completed on 8 mg/kg, the Transition Period will last 7 weeks. For those on 6 mg/kg, the Transition Period will last 5 weeks. However, during the double-blind Transition Period, some subjects may experience adverse events (AEs). If this should occur, the subject may be down titrated to one level above the minimal dose. The overall duration of the study will be up to 59 weeks. The overall duration of the Transition Period may thus be as short as 2 weeks or prolonged to as many as 11 weeks.
The Open Label Period will continue for up to a maximum of 59 weeks (approximately 15 months).
At the end of the study, Eisai will continue to supply zonisamide as part of this open-label extension protocol until the marketing authorisation of zonisamide for this indication or further development in this indication is stopped. In countries where no marketing authorisation will be applied for, Eisai has a compassionate use policy which can be applied for, if required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zonisamide |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subject has completed the double-blind study E2090-E044-312.
- Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent.
- Subject is male or female aged 6 to 18 years who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent.
- Subject is in general good health as determined by medical history, physical exam and screening laboratory results.
Key exclusion criteria (12 listed)
- Subject has a body weight < 20 kg.
- Subject has developed a history of renal calculi or renal insufficiency (creatinine level > 135 µmol/l (1.5 mg/dl).
- Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
- Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its excipients.
- Female subject of 10 years of age or greater, or of child bearing potential (i.e. started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e. oral contraceptive pill, surgical sterilization, an implant or injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication. NOTE: Should a female subject become of child bearing potential during the study, they must be reconsented in order to given consent to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception.
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 |
|---|---|---|
| ZonisamideAlso: ZonegranTransition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks. | Drug | 1 |
Primary outcome
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency
Time frame: Week 1 through Week 59
Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.
3 secondary outcomes
Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period
Time frame: Baseline through Week 59
Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period
Time frame: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313
Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period
Time frame: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Rob van Maanen, M.D., MFPM study director
Eisai Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zonisamide in people with Partial Seizures, run by Eisai Limited at 1 site 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 4 inclusion and 12 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 25 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 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency (time frame: Week 1 through Week 59). 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 25 Jan 2016.