This trial is active, not recruiting.

Condition partial onset seizures
Treatment zonisamide tablets
Sponsor Eisai Inc.
Start date March 2012
End date August 2013
Trial size 700 participants
Trial identifier NCT01830868, E2090-E044-410


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
zonisamide tablets 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.

Primary Outcomes

Retention Rate of Zonisamide (ZNS) after 6 months from Baseline
time frame: Up to 6 months

Secondary Outcomes

Change in Seizure Frequency after 3 and 6 months from Baseline
time frame: Baseline, 3 months and 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Hajo Hamer, Dr.
Description Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Eisai Inc..