Status:
COMPLETED
Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
Lead Sponsor:
Eisai Limited
Conditions:
Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
Eligibility Criteria
Inclusion
- Male or female patients aged 18-75.
- Able and willing to give written informed consent in accordance with the ICH GCP Guidelines.
- Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum βHCG 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.
- Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria.
- Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card.
- 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.
Exclusion
- History of status epilepticus within the last 5 years.
- 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.
- Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation.
- Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
- Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease.
- Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides.
- Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol.
- Any patient contraindicated for Zonegran treatment as per attached SmPC.
- Any patient who is pregnant and/or lactating.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00215592
Start Date
October 1 2005
Last Update
January 8 2016
Active Locations (33)
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1
Universitatsklinikum fur Neurologie
Innsbruck, Austria, 6020
2
Danish Epilepsy Center
Dianalund, Denmark, 4293
3
The Epilepsy Clinic
Glostrup Municipality, Denmark, 2600
4
Centre Hospitalier d'Annecy
Annecy, France, 74011