Methylphenidate in Childhood Apraxia of Speech

NCT05185583 | Completed Phase 2 DMC

• 1 other identifier: 77169
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 be compared between MPH intake and placebo intake.

Conditions

Childhood Apraxia of Speech

Keywords

Childhood Apraxia of Speech; Methylphenidate; Ritalin; Developmental Verbal Apraxia; Apraxia, Verbal; Attention Deficit-Hyperactivity Disorder; Central Stimulants; Central Nervous System (CNS) Stimulants; Intelligibility, Speech

Outcome Measures

Primary Outcomes (1)

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

  Single word speech intelligibility will be measured using the Preschool Speech Intelligibility Measure (PSIM). Twenty (20) items from the PSIM will be administered at each testing time point. Participants are required to repeat each test word after the researcher. Higher scores are indicative of greater unintelligibility (range 0-80). Mean change from baseline will be reported at the group level.

  Baseline and 4 weeks

Secondary Outcomes (16)

• Change From Baseline in Assessment of the Intelligibility of Dysarthric Speech-II (ASSIDS-II) Score at 4 weeks

  Baseline and 4 weeks

• Number of children at screening who refuse, are eligible, or are ineligible (and reason).

  At study recruitment, up to 4 weeks before starting treatment.

• Number of children who withdraw, discontinue, and/or experience 1 or more protocol violations.

  During the 4 week treatment phase.

• Adherence to dose regimen during each 4 week treatment period

  4 weeks

• Parent/caregiver experience of tolerability and utility

  Baseline and 4 weeks

Other Outcomes (8)

• Change From Baseline in maximum phonation time at 4 weeks

  Baseline and 4 weeks

• Change from Baseline in vowel space of speech at 4 weeks

  Baseline and 4 weeks

• Change from Baseline in the Mel-frequency cepstral coefficient (MFCC) at 4 weeks

  Baseline and 4 weeks

Study Arms (2)

Sequence A: Methylphenidate, Placebo

EXPERIMENTAL

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.

Drug: Methylphenidate Hydrochloride; Drug: Placebo

Sequence B: Placebo, Methylphenidate

EXPERIMENTAL

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.

Drug: Methylphenidate Hydrochloride; Drug: Placebo

Interventions

Methylphenidate Hydrochloride DRUG

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.

Also known as: Ritalin 10

Sequence A: Methylphenidate, Placebo; Sequence B: Placebo, Methylphenidate

Placebo DRUG

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

Sequence A: Methylphenidate, Placebo; Sequence B: Placebo, Methylphenidate

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

Location

Related Publications (4)

• Fraile R, Saenz-Lechon N, Godino-Llorente JI, Osma-Ruiz V, Fredouille C. Automatic detection of laryngeal pathologies in records of sustained vowels by means of mel-frequency cepstral coefficient parameters and differentiation of patients by sex. Folia Phoniatr Logop. 2009;61(3):146-52. doi: 10.1159/000219950. Epub 2009 Jul 1.

  PMID: 19571549 BACKGROUND

• Sapir S, Ramig LO, Spielman JL, Fox C. Formant centralization ratio: a proposal for a new acoustic measure of dysarthric speech. J Speech Lang Hear Res. 2010 Feb;53(1):114-25. doi: 10.1044/1092-4388(2009/08-0184). Epub 2009 Nov 30.

  PMID: 19948755 BACKGROUND

• Vergis, Ballard, K. J., Duffy, J. R., McNeil, M. R., Scholl, D., & Layfield, C. (2014). An acoustic measure of lexical stress differentiates aphasia and aphasia plus apraxia of speech after stroke. Aphasiology, 28(5), 554-575. https://doi.org/10.1080/02687038.2014.889275

  BACKGROUND

• Vogel, A., Skarrat, J., Castles, J., Synofzik, M. . (2016). Video game-based speech rehabilitation for reducing dysarthria severity in adults with degenerative ataxia. European Journal of Neurology, 23(227).

  BACKGROUND

MeSH Terms

Conditions

Apraxias; Attention Deficit Disorder with Hyperactivity; Speech Intelligibility

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Speech; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Angela Morgan, PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 11, 2022
• Study Start: March 14, 2022
• Primary Completion: October 27, 2025
• Study Completion: October 27, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication of primary outcome
• Access Criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered.

Locations

AU (1)