Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Completed · Phase 2 · Has a placebo group

Conditions studied: Tuberous Sclerosis Complex

In brief

Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure

Key facts

Study ID

NCT02849457

Run by

Martina Bebin

People needed

84

Starts

2016-12-01

Expected to finish

2023-05-05

Last updated by the study team

2024-08-19

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• less than or equal to 6 months of age
• No history of seizures or infantile spasms, or evidence of subclinical electrographic seizures on a previous video EEG
• Meet genetic or clinical diagnostic criteria for TSC, the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, echocardiogram

You may not qualify if…

• Is greater than 6 months of age
• Has not been diagnosed with TSC
• History of seizures or infantile spasms, or evidence of subclinical electrographic seizures on a previous video EEG
• Has received any anticonvulsant medication including vigabatrin, other anti-seizure therapeutic agent including cannabidiol
• Has received an oral mTOR inhibitor such as everolimus or sirolimus
• Has taken an investigational drug, including but not limited to cannabidiol, as part of a research study 30 days prior to enrollment, or plans on taking an investigational drug at any time during the duration of the study
• Is currently enrolled, or plans on enrolling at any time during the duration of the study, in an experimental behavioral early intervention study
• Has a history of being born prematurely (born less than <30 weeks gestation at the time of delivery)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Beaumont Children's Hospital — Royal Oak, Michigan, United States
• Minnesota Epilepsy Group, PA — Saint Paul, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati's Children Hospital Medical Center — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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