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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 )

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Zonegran Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
Study Start Date : October 2005
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Zonisamide




Primary Outcome Measures :
  1. Seizure frequency, compared to baseline.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215592


Locations
Show Show 33 study locations
Sponsors and Collaborators
Eisai Limited
Investigators
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Study Director: Dr. Tone Bjaaland Eisai Limited
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Responsible Party: Eisai Limited
ClinicalTrials.gov Identifier: NCT00215592    
Other Study ID Numbers: E2090-E044-401
2005-001982-33 ( EudraCT Number )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs