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)

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

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.

Study Overview

• Status: Completed
• Conditions: Partial Onset Seizures
• Intervention / Treatment: Drug: Zonisamide tablets

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Austria
  • Ried, Austria
• Denmark
  • Hillerod, Denmark
• Germany
  • Asperg, Germany
  • Baesweiler, Germany
  • Berlin, Germany
  • Bielefeld, Germany
  • Dortmund, Germany
  • Eisenach, Germany
  • Erbach, Germany
  • Erlangen, Germany
  • Furth, Germany
  • Gladenbach, Germany
  • Hamburg, Germany
  • Hassfurt, Germany
  • Julich, Germany
  • Kastellaun, Germany
  • Lage, Germany
  • Lappersdorf, Germany
  • Lauf, Germany
  • Lohr am Main, Germany
  • Malchin, Germany
  • Monchengladbach, Germany
  • Munchen, Germany
  • Neuburg an der Donau, Germany
  • Neusass, Germany
  • Osnabruck, Germany
  • Remscheid, Germany
  • Saarbrucken, Germany
  • Schorndorf, Germany
  • Schwabisch Gmund, Germany
  • Senftenberg, Germany
  • Stralsund, Germany
  • Stuttgart, Germany
  • Ulm, Germany
  • Velen, Germany
• Norway
  • Drammen, Norway
• Sweden
  • Stockholm, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult Patients With Partial Onset Seizures

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Zonisamide tablets

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.; Other Names: ZNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Principal Investigator: Hajo Hamer, Dr., Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimated): April 12, 2013

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Partial Onset Seizures; AED; Antiepileptic; Retention Rate; Seizure Control; ZNS; Secondary generalization; Seizure freedom rates
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Zonisamide
• Other Study ID Numbers: E2090-E044-410