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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: Completed study of Tuberous Sclerosis Complex, sponsored by University of Alabama at Birmingham.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Physical/neurological exam, Video EEG, Developmental assessments, Blood draw from child and parents/guardian, and Seizure diaries.
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-09 |
| Est. Completion | 2018-12 |
What the finished NCT01767779 record still lists
NCT01767779 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 152-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Tuberous Sclerosis Complex appearing as the primary indexed condition, and to 0 interventions.
NCT01767779 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01767779's enrollment target sits among peer trials
40 6th of 8 higher than 3 of 8 other Tuberous Sclerosis Complex trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberous Sclerosis Complex trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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