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New treatment option 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?
Extended-Release Methylphenidate is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for sickle cell disease.
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 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.
- 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 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
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
- 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 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.