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

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00298818
First received: March 2, 2006
Last updated: May 19, 2008
Last verified: May 2008
  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 North Shore Long Island Jewish Health System:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298818

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

No publications provided

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
Study First Received: March 2, 2006
Last Updated: May 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Epilepsy
Mental Retardation
Developmental Disabilities

Additional relevant MeSH terms:
Developmental Disabilities
Epilepsy
Intellectual Disability
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014