Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex



Status:Recruiting
Conditions:Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:3/16/2019
Start Date:December 2016
End Date:May 2021
Contact:Jessica Krefting, RN
Email:jessicakrefting@uabmc.edu
Phone:205-975-2890

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Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC

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

The central hypothesis of this Phase IIb trial is that early identification of
electroencephalography (EEG) biomarkers and early treatment versus delayed treatment with
vigabatrin in infants with tuberous sclerosis complex (TSC) will have a positive impact on
developmental outcomes at 24 months of age. It would also prevent or lower the risk of
developing infantile spasms and refractory seizures. This preventative approach would be
expected to result in more favorable long-term cognitive, behavioral, developmental and
psychiatric outcomes and significantly improve overall quality of life. It is a randomized,
double-blind, placebo-controlled clinical trial design. Successful completion of this trial
will also advance the field by demonstrating the value of systematic surveillance with EEG in
asymptomatic infants with TSC.

Inclusion Criteria:

1. less than or equal to 6 months of age

2. No history of seizures or infantile spasms, or evidence of subclinical electrographic
seizures on a previous video EEG

3. Meet genetic or clinical diagnostic criteria for TSC, the latter based on current
recommendations for diagnostic evaluation, such as physical exam, neuroimaging,
echocardiogram

Exclusion Criteria:

1. Is greater than 6 months of age

2. Has not been diagnosed with TSC

3. History of seizures or infantile spasms, or evidence of subclinical electrographic
seizures on a previous video EEG

4. Has received any anticonvulsant medication including vigabatrin, other anti-seizure
therapeutic agent including cannabidiol

5. Has received an oral mTOR inhibitor such as everolimus or sirolimus

6. 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

7. Is currently enrolled, or plans on enrolling at any time during the duration of the
study, in an experimental behavioral early intervention study

8. Has a history of being born prematurely (born less than <30 weeks gestation at the
time of delivery)
We found this trial at
13
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Mustafa Sahin, MD, PhD
Phone: 617-919-1476
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: E. Martina Bebin, MD, MPA
Phone: 205-975-2890
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Klaus Werner, MD, PhD
Phone: 919-684-2292
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Mary K Koenig, MD
Phone: 713-500-5766
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Joyce Wu, MD
Phone: 310-206-4037
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Mary Zupanc, MD
Phone: 714-509-8642
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Katherine Taub, MD
Phone: 267-426-5171
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Cincinnati, Ohio 45229
Principal Investigator: Darcy Kreuger, MD, PhD
Phone: 513-636-9699
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Cincinnati, OH
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Palo Alto, California 94304
Principal Investigator: Brenda Porter, MD
Phone: 650-721-1458
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Royal Oak, Michigan 48073
Principal Investigator: Danielle Nolan, MD
Phone: 248-551-2275
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Royal Oak, MI
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Saint Louis, Missouri 63110
Principal Investigator: Michael Wong, MD, PhD
Phone: 314-454-4267
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Saint Louis, MO
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Saint Paul, Minnesota
Principal Investigator: Michael Frost, MD
Phone: 651-241-5206
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: William McClintock, MD
Phone: 202-476-4481
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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