NCT00298818

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

Enrollment Period

3.3 years

First QC Date

March 2, 2006

Last Update Submit

May 19, 2008

Conditions

EpilepsyMental RetardationDevelopmental Disabilities

Keywords

EpilepsyMental RetardationDevelopmental Disabilities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Epilepsy center

You may qualify if:

  • 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

You may not qualify if:

  • Sulfa allergy
  • Prior exposure to zonisamide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

EpilepsyIntellectual DisabilityDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Alan Ettinger, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 3, 2006

Study Start

August 1, 2002

Primary Completion

December 1, 2005

Study Completion

March 1, 2008

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations

US(1)