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OPEN LABEL, ZONEGRAN (ZONISAMIDE) IN PARTIAL ONSET SEIZURES - Article


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Seizures

Seizure


Clinical Trial: OPEN LABEL, ZONEGRAN (ZONISAMIDE) IN PARTIAL ONSET SEIZURES

This study is not yet open for patient recruitment.
Verified by Eisai Medical Research Inc September 2005

Sponsored by: Eisai Limited
Information provided by: Eisai Medical Research Inc
ClinicalTrials.gov Identifier: NCT00215592

Purpose

To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
Condition Intervention Phase
Epilepsy
 Drug: Zonegran
Phase IV

MedlinePlus related topics:  Epilepsy

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Seizure frequency, compared to baseline.
Secondary Outcomes: Safety, Quality of Life.

Study start: October 2005

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

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), 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 adequate barrier methods (ie a condom and spermicide, intrauterine device in place for at least 3 months or diaphragm and foam). 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 ZonegranTM or considered unlikely to comply with the protocol.
  8. Any patient contraindicated for ZonegranTM treatment as per attached SmPC.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00215592

Eisai Limited      0208 600 1400 

United Kingdom
      London,  United Kingdom

      Leeds,  United Kingdom

Study chairs or principal investigators

Simon Stillman,  Study Director,  Eisai Limited   

More Information

Study ID Numbers:  E2090-E044-401
Last Updated:  September 21, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00215592
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-27


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Page Updated: December 9, 2005
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