CompletedPhase 2

Methylphenidate in Childhood Apraxia of Speech

Australia18 participantsStarted 2022-03-14

Plain-language summary

The purpose of this study is to describe the possible effects of methylphenidate (MPH) on speech intelligibility in children with childhood apraxia of speech (CAS) aged 6-12 years. This outcome will be compared between MPH intake and placebo intake.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has childhood apraxia of speech * Aged 6-12 years * Can perform the speech tasks for the trial (able to speak single words and short sentences) * English as a first language * Has adequate hearing * Has a legally acceptable representative capable of understanding the informed consent document and providing consent on their behalf * Passes the health and medical examination including examination of heart rate and blood pressure for age and weight norms * Can commit to the time requirements of the trial * Lives within 250 kilometres of the study site (MCRI) * Able to swallow a capsule * Scores 13 or more out of 27 on either the inattention and/or hyperactivity subscales of the SNAP-IV Parent 18-Item Rating Scale, suggesting clinically significant symptoms of inattention and/or hyperactivity Exclusion Criteria: * Is unable to commit to the time requirements of the trial (8 weeks + 2 days) * Has a diagnosis of severe intellectual disability, or other significant neurodevelopmental conditions (e.g., Fragile X, Down Syndrome, etc.) * Has epilepsy or other seizure disorders * Is taking medication(s) for another health condition(s) that is known to interfere with MPH * Has any contraindication to the stimulant (methylphenidate) medication, including severe anxiety, depression, severe Tourette syndrome, glaucoma, psychotic symptoms, hypertension, congenital heart disease, known past or present diagnosed substance abuse or dependence * Has a score of moderate o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Preschool Speech Intelligibility Measure Score at 4 weeks

Timeframe: Baseline and 4 weeks

Trial details

NCT IDNCT05185583

SponsorMurdoch Childrens Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-27

View on ClinicalTrials.gov More Childhood Apraxia of Speech trials

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.