Effects of Methylphenidate on Speech in Children with Apraxia
A Phase II Proof-of-concept Trial of Methylphenidate in Children With Apraxia of Speech: a Double-blind, Randomised, Placebo-controlled, Cross-over Trial
PHASE2 · Murdoch Childrens Research Institute · NCT05185583
This study is testing if a medication called methylphenidate can help improve speech clarity in children aged 6-12 who have childhood apraxia of speech.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute (other) |
| Locations | 1 site (Parkville, Victoria) |
| Trial ID | NCT05185583 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of methylphenidate (MPH) on speech intelligibility in children aged 6-12 diagnosed with childhood apraxia of speech (CAS). It employs a randomized, double-blind, placebo-controlled, two-period crossover design, enrolling 24 participants who will receive either MPH or a placebo in two 4-week periods separated by a 2-day washout. The primary goal is to determine if MPH leads to greater improvements in speech intelligibility compared to placebo. Secondary objectives include assessing feasibility, tolerability, and various speech and language production metrics.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-12 with a diagnosis of childhood apraxia of speech who can perform specified speech tasks.
Not a fit: Patients who do not have childhood apraxia of speech or those with severe intellectual disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance speech intelligibility in children with childhood apraxia of speech, improving their communication abilities.
How similar studies have performed: While the use of methylphenidate for speech disorders is not widely tested, similar studies in related areas have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 or high risk of suicidality, assessed with the Columbia Suicidality Severity Rating Scale (C-SSRS) * Has used psychostimulants within the past 3 months (e.g., Ritalin, Concerta, Focalin) * Lives more than 250 kilometres from the study site * Unable to swallow a capsule
Where this trial is running
Parkville, Victoria
- Murdoch Children's Research Institute — Parkville, Victoria, Australia (RECRUITING)
Study contacts
- Principal investigator: Angela Morgan, PhD — Murdoch Childrens Research Institute
- Study coordinator: Angela Morgan, PhD
- Email: angela.morgan@mcri.edu.au
- Phone: +613 8341 6458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Childhood Apraxia of Speech, Methylphenidate, Ritalin, Developmental Verbal Apraxia, Apraxia, Verbal, Attention Deficit-Hyperactivity Disorder, Central Stimulants, Central Nervous System Stimulants