NCT07226219 Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
| NCT ID | NCT07226219 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2025-11-25 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine if patients with sickle cell disease (SCD) can consistently take a drug called Methylphenidate (MPH) daily, once a day for 4 weeks to help with any thinking, attention or schoolwork problems and if they have any side effects. The study will assess any thinking or attention problems participants may have both before taking this drug and after. Additionally, the study will assess the decision-making process of the caregiver that may influence using this drug or not. Primary Objective: • Assess the feasibility, acceptability, and adherence to MPH treatment in children with SCD and EF deficits. Secondary Objective: • Evaluate neurobehavioral and safety outcomes following MPH treatment. Exploratory Objective: • Evaluate decision-making and determinants influencing methylphenidate utilization among parents.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with SCD of any genotype * Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP) * Between the ages of 8.0 and 17.9 years \*Included if performance measure, rating scale or diagnostic criteria met (within the past 2 years): * \*Score at or below the 16th percentile on any 2 out of 4 performance measures: * NIH Toolbox Flanker * NIH Toolbox List Sorting * NIH Toolbox Dimensional Change Card Sort Test (DCST) * Wechsler Intelligence Scale for Children (WISC) -5/ Wechsler Adult Intelligence Scale (WAIS)-4 Digit Span Forward (DSF) * \*Score at or above the 84th percentile on any 1 out of 2 parent rating scales: * BRIEF-2 Global Executive * BASC-3 Attention * \*Have a documented diagnosis of attention deficit / hyperactivity disorder (any subtype) * English as the primary language * Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines * Negative pregnancy test Exclusion Criteria: * Primary language other than English * Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test * Uncontrolled seizures (seizure within the past 6 months) * Cardiomyopathy or known congenital structural cardiac defects * Stenotic valvular disease, left coronary artery stenosis, or history of myocarditis or pericarditis * History of heart arrhythmia including ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, QT prolongation or concomitant use of medications associated with QT prolongation * Two or more prior episodes of priapism * Blood pressure \>95th percentile at the three most recent visits consecutively (i.e., \>95th percentile reading at all three of the most recent hospital visits to St. Jude). * If blood pressure is \> 95th %ile compared to age-norms on the day of the baseline visit, a repeat blood-pressure reading will be performed both electronically and manually to confirm findings. * Stimulant medication within the past two weeks * Severe sensory loss * Previous adverse reaction to methylphenidate * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Currently prescribed another investigational medication. * Currently prescribed any of the following: * Phenobarbital (anticonvulsant) * Phenytoin (anticonvulsant) * Primidone (anticonvulsant) * Warfarin (anticoagulant) * Antipsychotic medications * Selective Serotonin Reuptake Inhibitor (SSRI) medications * Tricyclic antidepressant (TCA) medications * Vasopressor medications
Contact & Investigator
Andrew W. Heitzer, PhD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT07226219 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07226219 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07226219 currently recruiting?
Yes, NCT07226219 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT07226219 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT07226219 clinical trial?
NCT07226219 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Andrew W. Heitzer, PhD at St. Jude Children's Research Hospital. The trial plans to enroll 72 participants.
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