Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04968522




Registration number
NCT04968522
Ethics application status
Date submitted
2/06/2021
Date registered
20/07/2021
Date last updated
13/12/2022

Titles & IDs
Public title
FASST - Fetal Alcohol Spectrum Stimulant Trial
Scientific title
Attention Management Trial for Children With FASD - a N-of-1 Control Trial of Prescribed Stimulants for ADHD in FASD
Secondary ID [1] 0 0
RES-21-0000-248A
Secondary ID [2] 0 0
RES-21-0000-248A
Universal Trial Number (UTN)
Trial acronym
FASST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal Alcohol Spectrum Disorders 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methylphenidate Hydrochloride
Treatment: Drugs - Placebo
Treatment: Drugs - Methylphenidate hydrochloride
Treatment: Drugs - Methylphenidate Hydrochloride 18 MG
Treatment: Drugs - Dexamphetamine sulfate

Placebo Comparator: Placebo comparator 2 - Participants will be allocated a randomly allocated sequence of treatment. The randomisation will be in two-week pairs - so the order of treatment (A) and placebo (P) to be randomly assigned within each two-week cycle (over 8 weeks). Placebo will be matched in dose to their stimulant dose at enrolment to the trial as determined and titrated by their primary paediatrician. This dose will remain constant for the course of the trial (8 weeks). Placebo will be orally administered, unless this is not possible for clinical reasons.

Experimental: Stimulant - The stimulants used in the trial are commercially available and will be used in accordance with the approved labelling. Participants must be on a stable dose of stimulant medication for at last 1 month prior to the study. The dose is individualized and titrated by treating primary paediatrician. This will represent the starting dose for the trial, and this will remain stable through the course of the 8-week trial. This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. Based on pilot data from this group, psychostimulant medications prescribed in this population may include:
Methylphenidate IR
Methylphenidate LA
Dexamphetamine
Children will take the required number of capsules to match the total prescribed dose (e.g. 30mg Ritalin LA is 3x10mg capsules).


Treatment: Drugs: Methylphenidate Hydrochloride
This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin 10 will be administered at the child's prescribed dose and may include a half tablet (5mg) increment. Ritalin 10 will be encapsulated in full tablet (10mg) or half tablet (5mg) dose.

Treatment: Drugs: Placebo
The placebo is Maize Starch and Pregelatinised Maize Starch. The placebo will be encapsulated using the same capsule that is opaque so that participants cannot distinguish the two visually. Where the active mediation amount is small for the capsule, there will be additional Starcke 1500 (Maize Starch and Pregelatinised Maize Starch) added to fill the capsule so that the active drug and capsule also weigh approximately the same. The dose of placebo will be matched to the participants currently prescribed stimulant medication.

Treatment: Drugs: Methylphenidate hydrochloride
This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin LA will be administered at the child's prescribed total dose. Ritalin LA will be encapsulated.

Treatment: Drugs: Methylphenidate Hydrochloride 18 MG
This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Concerta (18mg) will be administered at the child's prescribed total dose. Concerta will be encapsulated.

Treatment: Drugs: Dexamphetamine sulfate
This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Dexamphetamine (10mg) will be administered at the child's prescribed total dose. Dexamphetamine will be encapsulated.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in ADHD symptoms - teacher report - between placebo and stimulant
Timepoint [1] 0 0
Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total)
Primary outcome [2] 0 0
Change in ADHD symptoms - parent report - between placebo and stimulant
Timepoint [2] 0 0
Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total)
Primary outcome [3] 0 0
Change in spatial working memory - between placebo and stimulant
Timepoint [3] 0 0
Day 3 of each trial week (8 weeks total)
Primary outcome [4] 0 0
Change in Visual Information Processing - between placebo and stimulant
Timepoint [4] 0 0
Day 3 of each trial week (8 weeks total)
Secondary outcome [1] 0 0
Change in child problem behaviour rating- between placebo and stimulant
Timepoint [1] 0 0
Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total)
Secondary outcome [2] 0 0
Change in functional Impairment- between placebo and stimulant
Timepoint [2] 0 0
Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total)
Secondary outcome [3] 0 0
Difference in side effects during placebo and stimulant phase
Timepoint [3] 0 0
Day 5 of each trial week (8 weeks total)
Secondary outcome [4] 0 0
Trial feasibility - recruitment rate
Timepoint [4] 0 0
End of 8 month active trial phase
Secondary outcome [5] 0 0
Trial feasibility - completion rate
Timepoint [5] 0 0
End of 8 month active trial phase
Secondary outcome [6] 0 0
Compliance
Timepoint [6] 0 0
End of 8 month active trial phase
Secondary outcome [7] 0 0
Assessment completion rate
Timepoint [7] 0 0
End of 8 month active trial phase
Secondary outcome [8] 0 0
Data completion reason
Timepoint [8] 0 0
End of 8 month active trial phase
Secondary outcome [9] 0 0
Adverse events
Timepoint [9] 0 0
End of 8 month active trial phase

Eligibility
Key inclusion criteria
Each patient must meet all of the following criteria to be enrolled in this trial:

- Is between the ages of 4 - 18 years at the time of randomization.

- Meet diagnostic criteria for FASD or at risk of FASD according to the Australian Guide
to the diagnosis of FASD.

- Is a patient of VicFAS or Developmental Paediatrics (Monash Health).

- Has a diagnosis of ADHD according to the DMS-IV criteria.

- Be on a stimulant medication for treatment of ADHD symptoms.

- Be on a stimulant medication as a primary treatment for ADHD.

- Be on a stable dose of stimulant medication for at last 1 month prior to the study.

- Provide a signed and dated informed consent form / and has a legally acceptable
representative capable of understanding the informed consent document and providing
consent on the participant's behalf.

- If seen by VicFAS/Developmental paediatrics between August 2019 - study commencement
date), parent/guardian must have provided verbal or written consent to the VicFAS
database PICF and selected 'yes' to the optional consent for contact for 'future
research'.
Minimum age
4 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include any of the following:

- Inability to read or speak sufficient English for either child or parent/guardian to
complete assessment tasks.

- Be on a medication for treatment of ADHD symptoms that is a medication other than
stimulants as a primary treatment for ADHD.

- Allergy/sensitivity to Starcke 1500 (Maize Starch and Pregelatinised Maize Starch).

- Unable to swallow capsules.

- Intracranial symptoms or pathology such as epilepsy, hydrocephalus, diagnosed
traumatic. brain injury or progressive intracranial tumours that may impact cognitive
and behavioural function (children with asymptomatic or static lesions will be
eligible).

- An abnormal ECG result at the time of screening deemed clinically significant by study
physician.

- Presence of a significant comorbid psychiatric or psychological (excluding ADHD,
oppositional defiant disorder, conduct disorder and pervasive development
disorder/autism spectrum disorder) including depressive disorder, anxiety disorder,
psychotic disorder, suicidality, Tic disorder, anorexia or bulimia nervosa

- Has a known hypersensitivity to starch or other compound relevant to placebo/capsules.

- Has had treatment with any other investigational drug within 4 weeks prior to
randomisation.

- If the participant is known to be pregnant, they cannot take part in this research
project.

- Parent/guardian not consenting to contact with paediatrician or school.

- Is deemed by their treating paediatrician to be medically unsafe for trial
participation.

- Child's school unwilling to participate in outcome assessments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Monash Medical Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is a double-blind, placebo controlled, series of N-of-1 trials of individualised
stimulant dose on ADHD symptomatology in children with FASD.

The broad aim of this study is to contribute new evidence towards understanding treatment
efficacy for ADHD symptoms in FASD.

Specific aims are:

1. To assess the ongoing effectiveness of stimulant medication prescribed for ADHD symptoms
in individual children with FASD of clinically prescribed stimulant medication compared
to placebo to control ADHD symptoms (using behavioural and cognitive measures) in
children with FASD and ADHD using a N-of-1 trial design.

2. To obtain pilot data to examine feasibility and tolerability of the planned N-of-1 trial
design in children with FASD and ADHD for future and larger studies that might seek to
examine if the different stimulant types are equally effective relative to placebo.

3. To review the multiple N-of-1 data to analyze key individual factors that mediate the
effect of stimulants relative to placebo on ADHD symptoms, including underlying child
factors (attention skills, cognitive function), sociodemographic factors and other
prenatal exposures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04968522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alison Crichton, PhD
Address 0 0
Monash Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alison Crichton, PhD
Address 0 0
Country 0 0
Phone 0 0
0428214717
Fax 0 0
Email 0 0
ali.crichton@monashhealth.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04968522