Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation
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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.
| 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 |
| 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) |
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 |
Epilepsy center
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| United States, New York | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| 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 Mental Retardation Mental Disorders Diagnosed in Childhood Mental Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations |
Signs and Symptoms Zonisamide Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Anticonvulsants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013