Phase 4 Stroke Trial, Recruiting NCT06526117 Sponsor: Vanderbilt University Medical Center Condition: Stroke
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Phase 4 Stroke Trial, Recruiting

NCT06526117
Recruiting Phase 4

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:

  • People who have been diagnosed with a specific type of sickle cell disease (called HbSS or HbSβ0), confirmed by a specialised blood test.
  • Children aged between 5 and 12 years old (assessments can take place up until the child's 13th birthday).
  • Children whose brain blood flow measurements (taken using a painless ultrasound test called TCD) show readings that fall within a certain elevated range, indicating a higher risk of stroke.
  • Children (aged 7 and above) who are able to give their own agreement to take part, alongside consent from a parent or legal guardian.
  • Children who are able to swallow a capsule.

Who may not be able to join:

  • Children who have previously had a stroke or a mini-stroke (TIA), or who show signs of moderate or severe neurological problems based on a standard screening questionnaire.
  • Children who have serious problems affecting other organs, or any other medical reason that would make the medication hydroxyurea unsafe for them.
  • Children who are already receiving blood transfusions or are already taking hydroxyurea.
  • Children whose blood counts or kidney function fall outside certain safe levels (confirm with trial site for specific values).
  • Children who have a history of seizures or have been diagnosed with epilepsy.
  • Children who have any metal in their body that would make an MRI scan unsafe.

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 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Michael R DeBaun, MD, MPH, Vanderbilt University Medical Center

Phone: 615-875-3040

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

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
5 August 2024
Est. completion
31 December 2029

Where this trial is recruiting

Nigeria

Primary endpoints

Incidence Rate of Clinical Stroke or TIA

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: 28 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