Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT00215592
First received: September 14, 2005
Last updated: June 26, 2014
Last verified: December 2012

September 14, 2005
June 26, 2014
October 2005
July 2007   (final data collection date for primary outcome measure)
Seizure frequency, compared to baseline.
Same as current
Complete list of historical versions of study NCT00215592 on ClinicalTrials.gov Archive Site
Not Provided
Safety, Quality of Life.
Not Provided
Not Provided
 
Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures

To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: Zonegran
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
Not Provided
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female 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 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.
  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.

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 sulfonamides.
  7. Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol.
  8. Any patient contraindicated for Zonegran treatment as per attached SmPC.
  9. Any patient who is pregnant and/or lactating.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Norway,   Italy,   France,   Denmark,   Austria,   United Kingdom
 
NCT00215592
E2090-E044-401, 2005-001982-33
Not Provided
Eisai Inc. ( Eisai Limited )
Eisai Limited
Not Provided
Study Director: Dr. Tone Bjaaland Eisai Limited
Eisai Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP