Multiple Sclerosis Trial, Recruiting NCT06160310 Sponsor: David M. Ritter Condition: Multiple Sclerosis
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Multiple Sclerosis Trial, Recruiting

NCT06160310
Recruiting Not Applicable

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:

  • Pregnant people who have been diagnosed with Tuberous Sclerosis Complex (TSC) — either through clinical assessment or genetic testing — based on 2021 guidelines
  • Pregnant people who have been diagnosed with LAM (Lymphangioleiomyomatosis), a lung condition associated with TSC
  • Pregnant people who have an uncertain genetic result in the TSC1 or TSC2 gene (a result where it's unclear whether the gene change causes disease)
  • Pregnant people whose unborn baby has been assessed by the trial doctors as having a 50% chance of having TSC
  • Pregnant people whose unborn baby has shown signs that may suggest TSC, such as heart tumours (rhabdomyomas), brain lesions (tubers), or a specific type of brain growth (congenital subependymal giant cell astrocytoma) found before birth
  • Babies born to a parent who was already enrolled in this trial

Who may not be able to join:

  • Pregnant people who do not have TSC themselves but used preimplantation genetic testing (genetic screening of embryos before pregnancy) to test for TSC — unless the trial doctors determine they meet the fourth inclusion criterion above
  • Babies diagnosed with TSC whose birth mother was not enrolled in the trial

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: David M Ritter, 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

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
David M. Ritter
Registry
ClinicalTrials.gov
Start date
1 July 2023
Est. completion
1 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor adherence; Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor dosing; Safety of mTOR inhibitor in Pregnancy -- side effects; Maternal-Fetal Complications in TSC; Maternal Post-Partum Behavioral Health; Maternal Post-Partum Mental Health; Optimum Time of Fetal Imaging for TSC

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov