A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.
Other Name: Zonegran
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136954
|Firenze, 50132, FI, Italy, 50132|
|Study Director:||Rob van Maanen, M.D., MFPM||Eisai Limited|