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)

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830868
• Other study ID #: E2090-E044-410
• Status: Completed
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Partial Onset Seizures
• Seizures

Intervention

Drug:
• Zonisamide tablets
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

Austria,  Denmark,  Germany,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate of Zonisamide (ZNS) after 6 months from Baseline	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.	Up to 6 months
Secondary	Change in Seizure Frequency after 3 and 6 months from Baseline	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.	Baseline, 3 months and 6 months