Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001044516
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
7/10/2015
Date last updated
8/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Methylphenidate in Adults with Severe Traumatic brain injury for the Enhancement of Recovery (MASTER)
Scientific title
A pilot study of the effects of Methylphenidate (MPD) on cognition, mood, behaviour, participation and quality of life after severe traumatic brain injury in adults
Secondary ID [1] 287415 0
Nil
Universal Trial Number (UTN)
U1111-1173-9960
Trial acronym
MASTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 296377 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296383 296383 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 296648 296648 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3-month randomised double-blind placebo-controlled trial with oral active or placebo medication (Methylphenidate, Ritalin long acting 10mg DAILY for the first 7 days, to be increased to 20mg DAILY for 5 days) to be administered over 12 days and followed up for 3 months to assess outcomes. The medication will be administered by registered nursing staff on inpatient Brain Injury Unit.The principal researchers (Drs Browne and Bui) or MD Medical students will be undertaking assessments of attention and cognition as well as participation, mood and quality of life measures.

All participants will be given a baseline assessment and then undergo further assessments after administration of either active or placebo medication.
Intervention code [1] 292766 0
Treatment: Drugs
Intervention code [2] 292789 0
Rehabilitation
Comparator / control treatment
Methylphenidate (Ritalin LA) 10mg and then increased to a 20mg after 7 days compared with placebo, which will contain microcellulose. Total duration of treatment with either active agent or placebo is 12 days. All patients are randomised at enrolment to active or placebo. Methylphenidate or placebo ceased on day 12 and follow up assessment at 3 months.
Control group
Placebo

Outcomes
Primary outcome [1] 296028 0
Attention, assessed by Paced Auditory Serial Addition Test (PASAT)
Timepoint [1] 296028 0
Day 1, day 5, day 12, day 19, day 96
Primary outcome [2] 296146 0
Attention, assessed by Digit Span Test (DST)
Timepoint [2] 296146 0
Days 1,5,12,19,96
Primary outcome [3] 296147 0
Working memory, assessed by Symbol Digit Modality Test (SDMT)
Timepoint [3] 296147 0
Days 1,5,12,19,96
Secondary outcome [1] 317282 0
Quality of life as assessed by World Health Organisation Quality of Life-Bref (WHOQOL-Bref).
Timepoint [1] 317282 0
Day 96
Secondary outcome [2] 317616 0
Review of hospital records to assess length of inpatient stay
Timepoint [2] 317616 0
From date of enrolment to day 96 of participation
Secondary outcome [3] 317617 0
Side effects as measured by side effect questionnaire which has been designed specifically for this study
Timepoint [3] 317617 0
From date of enrolment to days 12,19,96 of participation
Secondary outcome [4] 317618 0
Hospital Anxiety and Depression Scale
Timepoint [4] 317618 0
From date of enrolment to days 1,5,12,19,96
Secondary outcome [5] 317872 0
Mayo-Portland Adaptability Inventory-4 (MPAI-4)
Timepoint [5] 317872 0
From date of enrolment to day 96 of participation

Eligibility
Key inclusion criteria
A participant is identified to be eligible if they are aged between 18-65yo, have a new traumatic brain injury within the past 6 months, a measurable PTA of greater than 7 days.
All participants need to be able to give informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking
Dysphasia
Current treatment with psycho-active medications
cardiac events
hypertension
abnormal ECG
tics
post-traumatic seizures
pregnancy (negative bhCG)
prior history of alcohol or drug abuse
Any medications which are contra-indicated with MPD: monoamine oxidase inhibitors, clonidine, dopamine agonists or antagonists, certain anaesthetics

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)
The participant will be enrolled into the study after informed consent has been obtained if the participant has met all inclusion criteria and has none of the exclusion criteria. The participant will receive a study enrolment number which allocates them to either active or placebo treatment. This study number has been randomly generated by a computer. This study number will be used to record information on the database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All eligible patients who consent will be enrolled into the study. The participant will be randomly allocated to receive either active or placebo treatment via a computer generated random number.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
At the completion of the study, un-blinding of the code will allow identification of participants into the two treatment arms. Subsequent statistical analysis will employ parametric techniques to determine within-subject and between-subject effects. Independent samples t tests will be used to test the null hypothesis that MPD does not affect performance on attentional tests, mood, participation, and quality of life. ANOVA tests will be used to assess the effect of repeated performance on the assessments. Regression analyses will be used to assess the influence of independent factors, such as age, gender, injury type and severity. This pilot study will provide valuable information on effect sizes of the instruments to allow appropriate sample size calculation for a future, larger, appropriately-powered randomised, double-blind trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4303 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde

Funding & Sponsors
Funding source category [1] 291983 0
Self funded/Unfunded
Name [1] 291983 0
Country [1] 291983 0
Primary sponsor type
Hospital
Name
Royal Rehab
Address
235 Morrison Rd
Ryde
NSW 2112
Country
Australia
Secondary sponsor category [1] 290649 0
None
Name [1] 290649 0
None
Address [1] 290649 0
None
Country [1] 290649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293475 0
Northern Sydney Local Health District Human Research Ethics Committee (EC0012)
Ethics committee address [1] 293475 0
Level 13 Kolling Building
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Ethics committee country [1] 293475 0
Australia
Date submitted for ethics approval [1] 293475 0
25/09/2015
Approval date [1] 293475 0
02/12/2015
Ethics approval number [1] 293475 0
2/12/2015

Summary
Brief summary
The research aims to learn more about the potential benefits of methylphenidate (Ritalin) as people recover from traumatic brain injury. Ritalin is a stimulant medication, most-widely known for its use in children with Attention Deficit Hyperactivity Disorder. It works by increasing the concentrations of certain neurotransmitters within the brain, especially those involved in attentional processes.

Past studies have shown that methylphenidate has been effective in patients with a traumatic brain injury in improving attention. This study looks at whether it not only improves attention but also day to day function and sense of well-being after three months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60066 0
Dr Tram Anh Bui
Address 60066 0
Royal Rehab
235 Morrison Rd
Ryde
NSW 2112
Country 60066 0
Australia
Phone 60066 0
+61 29808 9222
Fax 60066 0
+61 29809 6071
Email 60066 0
tram.bui@royalrehab.com.au
Contact person for public queries
Name 60067 0
Dr Stuart Browne
Address 60067 0
Royal Rehab
235 Morrison Rd
Ryde
NSW 2112
Country 60067 0
Australia
Phone 60067 0
+61 29808 9222
Fax 60067 0
+61 29809 6071
Email 60067 0
stuart.browne@royalrehab.com.au
Contact person for scientific queries
Name 60068 0
Dr Clayton King
Address 60068 0
Royal Rehab
235 Morrison Rd
Ryde
NSW 2112
Country 60068 0
Australia
Phone 60068 0
+61 29808 9222
Fax 60068 0
+61 29809 6071
Email 60068 0
clayton.king@royalrehab.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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