NCT00001149

Brief Summary

This study is designed to evaluate patients with uncontrolled seizures. Seizures can be associated with and monitored by abnormal electrical activity in the brain. In this study researchers will use video-electroencephalography (EEG) to monitor patients with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The video-EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur. In addition to monitoring electrical activity of the brain, researchers will take frequent antiepileptic drug blood levels. These measures will allow researchers to learn more about how each drug is absorbed and metabolized in the body. The information collected in the study will be used to place patients into other scientific studies testing new therapies for epilepsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 1975

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1975

Completed
24 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

AnticonvulsantsIntensive MonitoringEpilepsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
History of uncontrolled seizures, at the present time, at least during 6 months of the past 3 years, and preferably a continuous pattern of seizures during the few months prior to admission. Seizure frequency, by history, must be sufficient to make video monitoring effective. Priority will be given to patients whose seizures occur once or more per day. Patients of any age may be accepted. Patients (and parents or guardians, if applicable) must express willingness to cooperate with the entire protocol, to be willing to undergo further diagnostic tests if needed, and to return for follow up evaluation at intervals as needed.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Theodore WH, Porter RJ, Penry JK. Complex partial seizures: clinical characteristics and differential diagnosis. Neurology. 1983 Sep;33(9):1115-21. doi: 10.1212/wnl.33.9.11515.

    PMID: 6684245BACKGROUND
  • Penry JK, Porter RJ, Dreifuss RE. Simultaneous recording of absence seizures with video tape and electroencephalography. A study of 374 seizures in 48 patients. Brain. 1975 Sep;98(3):427-40. doi: 10.1093/brain/98.3.427.

    PMID: 1182486BACKGROUND
  • Altshuler LL, Devinsky O, Post RM, Theodore W. Depression, anxiety, and temporal lobe epilepsy. Laterality of focus and symptoms. Arch Neurol. 1990 Mar;47(3):284-8. doi: 10.1001/archneur.1990.00530030050016.

    PMID: 2106868BACKGROUND

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

November 1, 1975

Study Completion

January 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-01

Locations