Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00215592
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 8, 2016
Study Start Date  ICMJE October 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Seizure frequency, compared to baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00215592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Safety, Quality of Life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
Official Title  ICMJE An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
Brief Summary To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: Zonegran
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2007)
1000
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Denmark,   France,   Germany,   Italy,   Norway,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215592
Other Study ID Numbers  ICMJE E2090-E044-401
2005-001982-33 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Limited )
Study Sponsor  ICMJE Eisai Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr. Tone Bjaaland Eisai Limited
PRS Account Eisai Inc.
Verification Date November 2015

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