Clinical trial for Sickle Cell Disease
Official title Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
ClinicalTrials.gov ID: NCT07226219
What this study is testing
What is Extended-Release Methylphenidate?
an investigational oral medication being studied to help children with sickle cell disease who have attention and executive function problems. is designed to increase dopamine and norepinephrine activity in the brain, which can improve attention and focus.
Also referred to as MPH.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if children with sickle cell disease can reliably take methylphenidate each day and whether it improves attention, thinking, and school work, while monitoring safety.
- Who it's for
- Children with sickle cell disease who have problems with attention, executive function, or learning.
- What's involved
- Participants will take a pill of methylphenidate once daily for four weeks and will have visits and simple tests to check thinking, attention, and any side effects.
- Time commitment
- The study lasts about four weeks with regular clinic visits and assessments during that time.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17
You may be able to join if
- Diagnosed with SCD
- Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
- NIH Toolbox Flanker
- NIH Toolbox List Sorting
- NIH Toolbox Dimensional Change Card Sort Test (DCST)
You likely can't join if
- Primary language other than English
- Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test (ever)
- 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...
See the full eligibility criteria
- Diagnosed with SCD
- Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
- 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)
- 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 caregiver willing to participate and provide consent/assent according to institutional guidelines
- Negative pregnancy test in female participant of childbearing age
- Primary language other than English
- Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test (ever)
- 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.
- Diagnosed with sickle cell-hereditary persistence of fetal hemoglobin (HbSHPFH), sickle cell homozygous C (CC), Hb S/N-Baltimore, or other rare genotypes that would preclude the participant from having the classic...
- Phenobarbital (anticonvulsant)
- Phenytoin (anticonvulsant)
- Primidone (anticonvulsant)
- Warfarin (anticoagulant)
- Antipsychotic medications
- Selective Serotonin Reuptake Inhibitor (SSRI) medications
- Tricyclic antidepressant (TCA) medications
- Vasopressor medications
The study team makes the final eligibility decision.
Where it is enrolling
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Memphis, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.