Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zonisamide tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult Patients With Partial Onset Seizures
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hajo Hamer, Dr. | Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ried | Austria | |||||
Not provided
Not provided
Not provided
Not provided
|
|
| Hillerød |
| Denmark |
| Asperg | Germany |
| Baesweiler | Germany |
| Berlin | Germany |
| Bielefeld | Germany |
| Dortmund | Germany |
| Eisenach | Germany |
| Erbach im Odenwald | Germany |
| Erlangen | Germany |
| Fürth | Germany |
| Gladenbach | Germany |
| Hamburg | Germany |
| Haßfurt | Germany |
| Jülich | Germany |
| Kastellaun | Germany |
| Lage | Germany |
| Lappersdorf | Germany |
| Lauf | Germany |
| Lohr a. Main | Germany |
| Malchin | Germany |
| Mönchengladbach | Germany |
| München | Germany |
| Neuburg an der Donau | Germany |
| Neusäß | Germany |
| Osnabrück | Germany |
| Remscheid | Germany |
| Saarbrücken | Germany |
| Schorndorf | Germany |
| Schwäbisch Gmünd | Germany |
| Senftenberg | Germany |
| Stralsund | Germany |
| Stuttgart | Germany |
| Ulm | Germany |
| Velen | Germany |
| Drammen | Norway |
| Stockholm | Sweden |
| ID | Term |
|---|---|
| D000078305 | Zonisamide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided