A Phase II Proof-of-concept Trial of Methylphenidate in Children With Apraxia of Speech: a Double-blind, Randomised, Placebo-controlled, Cross-over Trial

Who is this study for? Children with apraxia of speech
What treatments are being studied? Methylphenidate Hydrochloride
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Murdoch Children's Research Institute
Parkville
Time Frame
Start Date: 2022-03-14
Completion Date: 2025-10-27
Participants
Target number of participants: 18
Treatments
Experimental: Sequence A: Methylphenidate, Placebo
Participants will first receive methylphenidate capsules twice daily for four weeks. Doses will be administered four hours apart. The maximum dose is determined based on the participant's weight. After a 2-day washout, participants then receive Placebo (matching methylphenidate capsules) twice daily for four weeks.
Experimental: Sequence B: Placebo, Methylphenidate
Participants will first receive Placebo capsules twice daily for four weeks. Doses will be administered four hours apart. After a 2-day washout, participants then receive methylphenidate capsules (matching Placebo capsules) twice daily for four weeks. The maximum dose is determined based on the participant's weight.
Related Therapeutic Areas
Sponsors
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov

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