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COMPLETED
NCT05185583
PHASE2

Methylphenidate in Childhood Apraxia of Speech

Sponsor: Murdoch Childrens Research Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2022-03-14

Completion Date

2025-10-27

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Methylphenidate Hydrochloride

Participants will receive twice daily doses of Methylphenidate Hydrochloride four hours apart. There will be three dosage schedules, determined based on three weight ranges (20-30kg; 30-40kg; ≥40kg). For children weighing 20-30kg, the maximum daily dose will be 20mg. For children weighing 30-40kg, the maximum daily dose will be 30mg. For children weighing ≥40kg, the maximum daily dose will be 40mg.

DRUG

Placebo

Participants will receive twice daily doses of placebo capsules. Gelatine placebo capsules will contain hypromellose, an inert substance.

Locations (1)

Murdoch Children's Research Institute

Parkville, Victoria, Australia