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Sirolimus for Tuberous Sclerosis (TSC-STEPS Trial)
TSC-STEPS Trial Summary
This trial is studying whether sirolimus can prevent or delay seizure onset in infants with Tuberous Sclerosis Complex.
TSC-STEPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTSC-STEPS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 4 trial • 293 Patients • NCT00118742TSC-STEPS Trial Design
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Who is running the clinical trial?
Media Library
- I have been treated with seizure medications, special diets, or mTOR inhibitors.I have been diagnosed with TSC through clinical tests or genetic analysis.I was born significantly premature or had complications at birth risking seizures or developmental delays.I have had, or will have, brain surgery within 3 months of starting the trial.My baby is between 0-6 months old and corrected age is at least 39 weeks.I have a condition linked to TSC that needs mTOR treatment.I do not have any serious illness or active infections currently.I have had seizures or they were found on an EEG.
- Group 1: Sirolimus
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many research locations are participating in this investigative trial?
"This trial has been extended to 8 sites, including the medical centres at Stanford University (Palo Alto), Washington University -- St. Louis (Saint Louis), and Boston Children's Hospital (Boston). The other 5 locations will be listed in subsequent communications."
What potential dangers do patients face when taking Sirolimus?
"Based on the information at hand, our team provides Sirolimus a safety score of 2 due to data suggesting its efficacy has yet to be empirically proven."
Is this experiment still enlisting participants?
"Affirmative. As verified by clinicaltrials.gov, this medical trial is actively recruiting participants since its initial post date on October 13th 2021 and the recent edit it underwent on September 2nd 2022. The experiment calls for 64 individuals to be recruited from 8 separate sites."
What are the aims of this research endeavor?
"This 12-month study will primarily evaluate the safety of sirolimus in terms of adverse events, but also assess neurodevelopmental outcomes after treatment, the efficacy of precise dosing for this particular therapy, and EEG biomarkers to measure neuronal connectivity."
What is the cap on the number of individuals involved in this research?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently seeking suitable participants. It was first posted on October 13 2021 and most recently amended on September 2 2022 with a requirement for 64 patients from 8 locations."
Do I meet the qualifications to participate in this trial?
"64 infants with aura are being accepted into the research trial. The necessary criteria includes a corrected age of at least 39 weeks, and they must be below 7 months old when randomized for treatment initiation. Additionally, applicants need to have been diagnosed clinically or genetically as having tuberous sclerosis complex (TSC)."
Are there any other research projects that have incorporated Sirolimus into their methods?
"Currently, 125 clinical trials examining Sirolimus are underway. Of those experiments, 13 have progressed to the third phase of testing. The majority of these studies are situated in Cincinnati, Ohio while other locations across the US host a total of 1074 sites conducting this research."
What is the usual purpose of prescribing Sirolimus?
"Sirolimus is a viable therapy for the prevention of transplant rejection, as well as diseases affecting the liver and kidneys."
Is the minimum age requirement for this clinical trial higher than twenty years old?
"This clinical trial requires infants aged 1 Day to 6 Months for enrollment. There are 194 other trials that cater specifically to minors and 600 studies designated for elderly patients."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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