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OpenTrials
Completed

NCT Number: NCT00298818

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Eisai Inc.

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2008
First posted
Mar 3, 2006
Registry last updated
May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.