Clinical trial NCT01830868: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Onset Seizures
Keywords: ZNS
AED
Partial Onset Seizures
Retention Rate
Seizure Control
Antiepileptic
Secondary generalization
Seizure freedom rates
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients With Partial Onset Seizures

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Retention Rate of Zonisamide (ZNS) after 6 months from Baseline
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in Seizure Frequency after 3 and 6 months from Baseline
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Ried
country: Austria
city: Hillerod
country: Denmark
city: Asperg
country: Germany
city: Baesweiler
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Dortmund
country: Germany
city: Eisenach
country: Germany
city: Erbach
country: Germany
city: Erlangen
country: Germany
city: Furth
country: Germany
city: Gladenbach
country: Germany
city: Hamburg
country: Germany
city: Hassfurt
country: Germany
city: Julich
country: Germany
city: Kastellaun
country: Germany
city: Lage
country: Germany
city: Lappersdorf
country: Germany
city: Lauf
country: Germany
city: Lohr am Main
country: Germany
city: Malchin
country: Germany
city: Monchengladbach
country: Germany
city: Munchen
country: Germany
city: Neuburg an der Donau
country: Germany
city: Neusass
country: Germany
city: Osnabruck
country: Germany
city: Remscheid
country: Germany
city: Saarbrucken
country: Germany
city: Schorndorf
country: Germany
city: Schwabisch Gmund
country: Germany
city: Senftenberg
country: Germany
city: Stralsund
country: Germany
city: Stuttgart
country: Germany
city: Ulm
country: Germany
city: Velen
country: Germany
city: Drammen
country: Norway
city: Stockholm
country: Sweden
Study officials:
affiliation: Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany
name: Hajo Hamer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: