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Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298818
First Posted: March 3, 2006
Last Update Posted: May 20, 2008
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.
Collaborator:
Eisai Inc.
Information provided by:
Northwell Health
  Purpose
The purpose of this study is to assess the efficacy and tolerability in "real-world" clinical practice, of adjunctive zonisamide treatment in adult patients with developmental disabilities and epilepsy.

Condition Phase
Epilepsy Mental Retardation Developmental Disabilities Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation / Developmental Disabilities

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Enrollment: 25
Study Start Date: August 2002
Study Completion Date: March 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:
While a number of randomized double-blind controlled trials have demonstrated the value of zonisamide in the treatment of seizures, such studies lend limited insight into the efficacy and tolerance of zonisamide in real-world clinical practice. Furthermore, randomized trials tend to inquire about negative effects, such as adverse reactions, while positive effects such as improvement in mood, or sense of well-being are not similarly categorized. In addition, there is little information about experience with zonisamide specifically in adult patients with mental retardation (MR) / developmental disabilities (DD). Anecdotal experience suggests that zonisamide is exceptionally well-tolerated, and is associated with an improved general sense of well-being and quality of life in non-DD patients. In patients with MR/DD, observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing antiepileptic drugs.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Epilepsy center
Criteria

Inclusion Criteria:

  • Male or Female, at least 18 years of age
  • Diagnosis of mental retardation
  • Uncontrolled seizures or intolerable side effects from current AEDs
  • Legal guardian is able to consent

Exclusion Criteria:

  • Sulfa allergy
  • Prior exposure to zonisamide
  Contacts and Locations
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): NCT00298818


Locations
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Eisai Inc.
Investigators
Principal Investigator: Alan Ettinger, MD Northwell Health
  More Information

Responsible Party: Alan Ettinger, MD / Chief of LIJ Comprehensive Epilepsy Center, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00298818     History of Changes
Other Study ID Numbers: 02.08.035
First Submitted: March 2, 2006
First Posted: March 3, 2006
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Northwell Health:
Epilepsy
Mental Retardation
Developmental Disabilities

Additional relevant MeSH terms:
Epilepsy
Intellectual Disability
Developmental Disabilities
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Zonisamide
Anticonvulsants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs