Phase 2 Multiple Sclerosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Babies who are between 0 and 6 months of age (in calendar months) at the time of joining, and whose age adjusted for early birth is at least 39 weeks
- Babies who have been confirmed to have Tuberous Sclerosis Complex (TSC), based on medical tests or genetic results
Who may not be able to join:
- Babies who have had seizures at any point before joining, including seizures detected on a brainwave test (EEG)
- Babies who have previously been treated with, or are currently taking, seizure medications, mTOR inhibitor drugs (such as sirolimus, rapamycin, or everolimus), a ketogenic-type special diet, or any other anti-seizure treatment, device, or procedure
- Babies who have taken part in another research study and received an experimental drug within the 30 days before the initial screening visit
- Babies who have a significant illness or active infection at the time of the initial screening visit
- Babies born before 30 weeks of pregnancy, or babies who had serious medical complications at birth or in the newborn period — beyond TSC itself — that could increase the risk of seizures or developmental delays (for example, brain injury from lack of oxygen, severe newborn infection, major surgery, or prolonged life support)
- Babies who have abnormal blood test results at the start of the study (such as results relating to kidney function, liver function, or blood cell production) that the trial doctor considers to be medically significant and potentially unsafe
- Babies who have had, or are expected to have, brain surgery within 3 months of the initial screening visit
- Babies who have a TSC-related condition for which mTOR treatment is already medically necessary (such as certain brain tumours or kidney tumours associated with TSC) (confirm with trial site)
- Babies who, in the opinion of the trial doctor, would not be able to meet the requirements of the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Darcy A Krueger, MD, PhD, Children's Hospital Medical Center, Cincinnati
Phone: 513-636-9669
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Efficacy -- time to seizure onset; Safety -- adverse events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.