Indicated as adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation. MedDRA version: 8.0 Level: pt Classification code 10061334
Conditions
Interventions
Pharmaceutical Form: Capsule*
Pharmaceutical Form: Capsule*
Pharmaceutical Form: Capsule*
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female adult patients aged 18-75 2) Able and willing to give written informed consent in accordance with the ICH GCP Guidelines. 3) Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum ßHCG at screening and negative urine pregnancy test at baseline/during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception as defined here is the oral contraceptive pill, surgical sterilization or hormonal intrauterine device in place for at least 3 months. Women who are less than 2 years post menopausal are considered to be of childbearing potential. 4) Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria. 5) Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card. 6) Patients should be receiving at least 1 but no more than 2 other AEDs as concomitant medication, and the dosage should be stable for at least 8 weeks before the baseline visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) History of status epilepticus within the last 5 years 2) Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed. Note investigators should consult included SmPC as a guide. 3) Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation. 4) Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency. 5) Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease. 6) Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulphonamides. 7)Subjects considered by the investigator to be an unsuitable candidate for receiving zonisamide or considered unlikely to comply with the protocol. 8) Any patient contraindicated for ZonegranTM treatment as per attached SmPC 9) Any patient who is pregnant and/or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and safety of adjunctive open label zonisamide treatment in patients with refractory partial seizures;Secondary Objective: None stated;Primary end point(s): The primary endpoint is the change from baseline to end of week 19 in partial seizure frequency. This will allow for a direct comparison of seizure frequency in the fixed dose period (beginning of week 16 - end of week 19) with the baseline seizure frequency, calculated as the average number of seizures/4 week period during 8 consecutive weeks prior to the baseline visit. | — |
Countries
Austria, Denmark, Finland, Germany, Italy, Sweden, United Kingdom
Outcome results
None listed