Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000975291
Ethics application status
Approved
Date submitted
3/11/2009
Date registered
11/11/2009
Date last updated
18/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised double blind, placebo-controlled study of Nefiracetam in patients with post- stroke apathy
Scientific title
In post stroke patients, treatment with nefiracetam decreases the severity of apathy
Secondary ID [1] 253170 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post stroke apathy 252114 0
Condition category
Condition code
Mental Health 252319 252319 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
450mg Nefiracetam (one capsule orally) twice daily for 12 weeks
Intervention code [1] 241497 0
Treatment: Drugs
Comparator / control treatment
placebo: one capsule oraly twice daily for 12 weeks. Capsules will be identical in shape size and colour to active medication, only without the active ingredient
Control group
Placebo

Outcomes
Primary outcome [1] 253184 0
Apathy scale(AS): is a clinician based questionnaire assessed with both the patient and the caregiver together
Timepoint [1] 253184 0
The AS will be administered at baseline (start of Randomized Control Trial (RCT); then at weeks 4, 8, 12, 24 and 36 weeks post baseline. The baseline assessment will take place no less than 8 weeks post stroke.
Secondary outcome [1] 262116 0
Clinical Global Impression Scale (CGI): clinician based assessment of overall functioning on a continuum from psychological or psychiatric sickness to health. Detects clinical change and placebo-drug differences.
Timepoint [1] 262116 0
CGI will be administered at baseline (start of RCT) then again at weeks 4, 8, 12, 24 and 36 weeks post baseline.
Secondary outcome [2] 262117 0
Barthel Index (BI): clinician rated assessment of the patient's daily functioning. provides baseline level and monitor improvement in activities of daily living over time
Timepoint [2] 262117 0
BI will be administered at baseline (start of RCT) and then at weeks 4, 8, 12, 24 and 36 weeks post baseline.
Secondary outcome [3] 262118 0
Functional Impact Measure (FIM): clinician rated assessment of severity of patient disability and functional outcome.
Timepoint [3] 262118 0
FIM will administered at screening (0-6 months post onset of stroke), baseline (start of RCT); then 4, 8, 12, 24, 36 weeks post baseline.
Secondary outcome [4] 262119 0
Stroke Impact Scale (SIS): a patient self-rated assessment of the impact of stroke on a patient's health and life
Timepoint [4] 262119 0
SIS will be administered at baseline (start of RCT); then at weeks 4,8,12,24 and 36 weeks post baseline
Secondary outcome [5] 262120 0
Euroquol 5-dimensions (EQ-5): a clinician rated scale to evaluate a patient's health status
Timepoint [5] 262120 0
EQ-5 will be administered at baseline (start of RCT); then at weeks 4,8,12,24 and 36 weeks post baseline

Eligibility
Key inclusion criteria
1. Clinical and neurological findings consistent with either hemispheric, brainstem or cerebellar stroke 2. apathy present after stroke 3. able to undergo assessment and take oral medication 4.be cared for by a reliable spouse who can be responsible for administering dose
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. patients with major depression post stroke 2. stroke resulting from aneurysm, ateriovenous malformation, head injury, intracranial tumour or neoplastic process 3. prestroke dementia 4. severe language comprehension deficits 5. comorbid alcohol or drug abuse 6. severe medical comorbidity 7. current use of neuroleptic or drugs repported to affect apathy 8. apathy resulting from any condition other than stroke 9. Severe renal disease: BUN >=17.85mmol/L; Creatinine >= 176.89 umol/L; proteinuria (dipstick >= +2

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?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
27/07/2010
Date of last participant enrolment
Anticipated
Actual
22/03/2013
Date of last data collection
Anticipated
Actual
31/12/2013
Sample size
Target
122
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 243963 0
Government body
Name [1] 243963 0
National Health and Medical Research Council
Country [1] 243963 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital and Health Service
Address
Alma St
Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 251317 0
None
Name [1] 251317 0
Address [1] 251317 0
Country [1] 251317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244078 0
South Metropolitain Area Health Service Human Research Ethics Committee
Ethics committee address [1] 244078 0
Fremantle Hospital and Health Service
Alma Street,
Fremantle, Western Australia 6160
Ethics committee country [1] 244078 0
Australia
Date submitted for ethics approval [1] 244078 0
17/11/2009
Approval date [1] 244078 0
29/01/2010
Ethics approval number [1] 244078 0
09/500

Summary
Brief summary
The successful psycho-physical rehabilitation of stroke victims remains challenging. Recent advances have resulted in progress in acute treatment of stroke, however post-acute rehabilitation remains basically unchanged. One reason for this is the high frequency of emotional and behavioural disorders post-stroke, such as apathy. Apathy is associated with greater deficits in activities of daily living, more severe cognitive deficits, longer hospital stay, and worse rehabilitation and functional outcomes. There are no known effective pharmacological or psychological treatments for apathy after stroke. We aim to determine if treatment with nefiracetam decreases the severity of post-stroke apathy. We will also test whether nefiracetam results in greater improvement on functional and social impairments, quality of life and cognition as compared to placebo.
Trial website
Trial related presentations / publications
A Randomized, Placebo-Controlled, Double-Blind Efficacy Study of Nefiracetam to Treat Poststroke Apathy. Starkstein, S. E. ; Brockman, S. ; Hatch, K. K. ; Bruce, D. G. ; Almeida, O. P. ; Davis, W. A. ; Robinson, R. G. Journal of Stroke and Cerebrovascular Diseases, May 2016, Vol.25(5), pp.1119-1127
Public notes

Contacts
Principal investigator
Name 30458 0
Prof Sergio Starkstein
Address 30458 0
Level 7, T Block
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 30458 0
Australia
Phone 30458 0
+61894312013
Fax 30458 0
Email 30458 0
sergio.starkstein@uwa.edu.au
Contact person for public queries
Name 13705 0
Prof Sergio Starkstein
Address 13705 0
Level 7, T Block
Fremantle Hospital
Fremantle WA 6160
Country 13705 0
Australia
Phone 13705 0
+61 8 9 431 2013
Fax 13705 0
Email 13705 0
ses@meddent.uwa.edu.au
Contact person for scientific queries
Name 4633 0
Prof Sergio Starkstein
Address 4633 0
Level 7, T Block
Fremantle Hospital
Fremantle WA 6160
Country 4633 0
Australia
Phone 4633 0
+ 61 8 9431 2013
Fax 4633 0
Email 4633 0
ses@meddent.uwa.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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