Phase 1 Sickle Cell Disease Trial, Recruiting NCT07226219 Sponsor: St. Jude Children's Research Hospital Condition: Sickle Cell Disease
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Phase 1 Sickle Cell Disease Trial, Recruiting

NCT07226219
Recruiting Phase 1

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:

  • You have been diagnosed with sickle cell disease (any type)
  • You are already enrolled in a program at the institution called SCCRIP (Sickle Cell Clinical Research Intervention Program)
  • You are between 8 and 17 years old (up to your 18th birthday)
  • In the past 2 years, you scored at or below the 16th percentile on at least 2 out of 4 specific thinking and attention tests (confirm with trial site which tests apply to you)
  • OR in the past 2 years, a parent rated your attention or thinking skills at or above the 84th percentile on one of two specific behaviour rating questionnaires, suggesting noticeable difficulties (confirm with trial site)
  • OR you have been formally diagnosed with ADHD (any type) in the past 2 years
  • English is your main language at home
  • Both the child and at least one parent are willing to take part and sign the required consent forms
  • If applicable, a negative pregnancy test is required before joining

Who may not be able to join:

  • English is not your primary language
  • You scored very low (below the 2nd percentile) on a standard IQ test called the WASI-2
  • You have had a seizure within the past 6 months that is not well controlled
  • You have a heart muscle disease (cardiomyopathy) or a heart defect you were born with
  • You have certain heart valve problems, a narrowing of a specific heart artery, or a history of heart muscle or heart lining inflammation
  • You have a history of certain abnormal heart rhythms, or take medicines known to affect heart rhythm (confirm with trial site)
  • You have had two or more episodes of a painful, long-lasting erection (called priapism)
  • Your blood pressure has been higher than the normal range for your age at your three most recent hospital visits in a row
  • You have taken stimulant medication (such as ADHD medication) within the past two weeks
  • You have severe hearing or vision loss
  • You have had a bad reaction to a medicine called methylphenidate in the past
  • You or your parent/guardian are unwilling or unable to sign the consent forms
  • You are currently taking part in another clinical trial involving an experimental medicine
  • You are currently taking any of the following medicines: phenobarbital, phenytoin, primidone (seizure medicines), warfarin (a blood thinner), antipsychotic medicines, SSRI antidepressants, tricyclic antidepressants, or vasopressor medicines (medicines used to raise blood pressure)

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 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Andrew W. Heitzer, PhD, St. Jude Children's Research Hospital

Phone: 888-226-4343

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 1
Sponsor
St. Jude Children's Research Hospital
Registry
ClinicalTrials.gov
Start date
25 November 2025
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Assess feasibility of methylphenidate; Assess acceptability of methylphenidate; Assess adherence to methylphenidate

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: 26 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