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
Who is this study for? Infant patients with tuberous sclerosis complex
What treatments are being studied? Vigabatrin
Status: Completed
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 6 months
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
University of California, Los Angeles
Los Angeles
Stanford University
Palo Alto
Washington, D.c.
Children's National Medical Center
Washington
Massachusetts
Boston Children's Hospital
Boston
Michigan
Beaumont Children's Hospital
Royal Oak
Minnesota
Minnesota Epilepsy Group, PA
Saint Paul
Missouri
Washington University in St. Louis
Saint Louis
North Carolina
Duke University
Durham
Ohio
Cincinnati's Children Hospital Medical Center
Cincinnati
Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia
Texas
University of Texas Health Science Center at Houston
Houston
Washington
Seattle Children's Hospital
Seattle
Time Frame
Start Date: 2016-12
Completion Date: 2023-05-05
Participants
Target number of participants: 84
Treatments
Placebo_comparator: Delayed Vigabatrin (Placebo)
Randomization will only occur after detection of epileptiform activity on EEG. Participants randomized to this arm will be treated with matching placebo until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on placebo, they will be eligible for Open label vigabatrin. Participants will be followed until 36 months of age.
Experimental: Early Vigabatrin
Randomization will only occur after detection of epileptiform activity on EEG. Participants randomized to this arm will be treated with vigabatrin until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on vigabatrin, they will be eligible for Open label vigabatrin. Participants will be followed until 36 months of age.
No_intervention: Watchful Waiting (Control Group)
Enrolled participants in this arm are those who never develop EEG abnormalities or clinical seizures during the length of the study. While all participants who enrolled in the study started in this group, participants were randomized upon development of EEG epileptiform activity. All participants who completed the study without developing EEG epileptiform activity or clinical seizures are reported in this group.
Authors
Related Therapeutic Areas
Sponsors
Leads: Martina Bebin
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)