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Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC
NCT01767779 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-09 |
| Est. Completion | 2018-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01767779
The ClinicalTrials.gov registry entry for NCT01767779 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Tuberous Sclerosis Complex appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01767779 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Alabama, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01767779?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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