Status:
COMPLETED
Methylphenidate in Childhood Apraxia of Speech
Lead Sponsor:
Murdoch Childrens Research Institute
Conditions:
Childhood Apraxia of Speech
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief 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 b...
Detailed Description
This is a randomised, double-blind, placebo-controlled, two-period crossover proof-of-concept trial of methylphenidate (MPH) for children with childhood apraxia of speech (CAS). 24 children aged 6 to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05185583
Start Date
March 14 2022
End Date
October 27 2025
Last Update
November 17 2025
Active Locations (1)
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1
Murdoch Children's Research Institute
Parkville, Victoria, Australia, 3052