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NCT01767779 · ClinicalTrials.gov registry record

Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC

A clinical trial of Tuberous Sclerosis Complex, sponsored by University of Alabama at Birmingham.

Completed
Registry status
40
Enrollment target
5
Study locations

NCT01767779 is a study of Tuberous Sclerosis Complex that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 152-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (74% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT01767779, a study of Tuberous Sclerosis Complex, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
40 participants
Enrollment target
5
Study locations

Study Summary

To determine whether EEGs during infancy is a reliable biomarker to identify TSC patients that will develop infantile spasms/epilepsy in the near future and thus are appropriate candidates for an antiepileptogenic drug trial. Since not all patients with TSC develop epilepsy, it would be useful to have a biomarker that could predict those patients destined to have epilepsy and thus identify those TSC patients most appropriate for an antiepileptogenic drug trial. A recent study suggests that treating TSC patients with an abnormal EEG prior to onset of infantile spasms with vigabatrin may improve neurological outcome, but the use of EEG as a reliable biomarker of future epilepsy has not been rigorously validated. In this specific aim, we will test the reliability of EEG in predicting future development of infantile spasms or epilepsy in TSC patients during the first year of life.

Conditions Studied

Study Locations (5)

Alabama

  • University of Alabama at Birmingham - Birmingham

California

  • UCLA - Los Angeles

Massachusetts

  • Boston Children's Hospital - Boston

Ohio

  • Cincinnati Children's Hospital - Cincinnati

Texas

  • University of Texas in Houston - Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2012-09
Est. Completion 2018-12

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT01767779

The ClinicalTrials.gov registry entry for NCT01767779 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 152-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (74% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tuberous Sclerosis Complex appearing as the primary indexed condition, and to 0 interventions.

NCT01767779 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Alabama, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01767779 about?

NCT01767779 is a clinical study titled "Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC". To determine whether EEGs during infancy is a reliable biomarker to identify TSC patients that will develop infantile spasms/epilepsy in the near future and thus are appropriate candidates for an antiepileptogenic drug trial. Since not all patients with TSC develop epilepsy, it would be useful to ha...

What is the current status of trial NCT01767779?

This trial is currently completed. The enrollment target is 40 participants. The study started on 2012-09. Estimated completion is 2018-12.

What conditions does trial NCT01767779 study?

This clinical trial studies the following conditions: Tuberous Sclerosis Complex.

Who is sponsoring clinical trial NCT01767779?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01767779 being conducted?

This trial has 5 study locations across Alabama, California, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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