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)

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.

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Key information

Conditions

Partial Onset Seizures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ried, Austria

About this study

Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Zonisamide tablets

Drug

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.

Other names: ZNS

Primary outcomes

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.

Secondary outcomes

Change in Seizure Frequency after 3 and 6 months from Baseline

Time frame: Baseline, 3 months and 6 months

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.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 12, 2013
Registry last updated: Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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