Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000338369
Ethics application status
Approved
Date submitted
10/07/2008
Date registered
17/07/2008
Date last updated
17/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Flecainide in amyotrophic lateral sclerosis - a potential neuroprotective strategy.
Scientific title
The effect of flecainide on the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised in patients with amyotrophic lateral sclerosis
Universal Trial Number (UTN)
Trial acronym
FANS -Flecainide in Amyotrophic Lateral Sclerosis - A Neuroprotective Strategy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor neuron disease 3397 0
Amyotrophic lateral sclerosis 3398 0
Condition category
Condition code
Neurological 3543 3543 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will only receive flecainide during the 32-week treatment phase; not during the initial 12-week lead-in phase. Patients will not receive anything in addition to their pre-existing medications during the lead-in phase.

Flecainide will be taken 50mg twice per day in the first week of the 32-week treatment phase, and 100mg twice per day thereafter. Patients will receive flecainide for 32 weeks. Oral mode of administration.
Intervention code [1] 3120 0
Treatment: Drugs
Comparator / control treatment
Patients will only receive placebo sugar pill during the 32-week treatment phase; not during the initial 12-week lead-in phase. Patients will not receive anything in addition to their pre-existing medications during the lead-in phase.

Placebo sugar pill will be taken 50mg twice per day in the first week of the 32-week treatment phase. 100mg twice per day thereafter. Patients will receive placebo for 32 weeks. Oral mode of administration.
Control group
Placebo

Outcomes
Primary outcome [1] 4445 0
Rate of change in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised
Timepoint [1] 4445 0
Lead-in phase: weeks 0, 4, 8 and 12.
Treatment phase: weeks 16, 20, 24, 28, 32, 36, 40 and 44.
Secondary outcome [1] 7510 0
Rate of change in grip strength using a Jamar dynamometer
Timepoint [1] 7510 0
Lead-in phase: weeks 0, 4, 8 and 12.
Treatment phase: weeks 20, 28, 36 and 44.
Secondary outcome [2] 7511 0
Rate of change in forced vital capacity using a portable spirometer
Timepoint [2] 7511 0
Lead-in phase: weeks 0, 4, 8 and 12.
Treatment phase: weeks 20, 28, 36 and 44.
Secondary outcome [3] 7512 0
Rate of change in sniff nasal inspiratory pressure
Timepoint [3] 7512 0
Lead-in phase: weeks 0, 4, 8 and 12.
Treatment phase: weeks 20, 28, 36 and 44.
Secondary outcome [4] 7513 0
Rate of change in neurophysiological index
Timepoint [4] 7513 0
Lead-in phase: weeks 0, 4, 8 and 12.
Treatment phase: weeks 20, 28, 36 and 44.
Secondary outcome [5] 7514 0
Peripheral nerve excitability using threshold tracking nerve excitability equipment.
Timepoint [5] 7514 0
Lead-in phase: weeks 0 and 12.
Treatment phase: weeks 20, 28, 36 and 44.
Secondary outcome [6] 7515 0
Cortical excitability using threshold tracking transcranial magnetic stimulation.
Timepoint [6] 7515 0
Lead-in phase: weeks 0 and 12.
Treatment phase: weeks 20, 28, 36 and 44.
Secondary outcome [7] 7516 0
6-metre walk test
Timepoint [7] 7516 0
Lead-in phase: weeks 0, 4, 8 and 12.
Treatment phase: weeks 20, 28, 36 and 44.
Secondary outcome [8] 7517 0
Survival
Timepoint [8] 7517 0
Throughout entire treatment phase

Eligibility
Key inclusion criteria
1. Diagnosis of "definite" or "probable" amyotrophic lateral sclerosis according to the revised El Escorial criteria (as defined by the Committee on Neuromuscular
2. Diagnosis of "possible" amyotrophic lateral sclerosis according to the revised El Escorial criteria plus abnormally reduced short intracortical inhibition on transcranial magnetic stimulation.
3. Disease duration of less than five years.
4. Sniff nasal inspiratory pressure of greater than 50% predicted.
5. Normal cardiac rhythm (as determined by electrocardiograph) and left ventricular function (assessed by echocardiography).
6. Ability to provide consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of dementia or major psychiatric disorder.
2. Involvement in other clinical trials
3. Pregnancy or lactation
4. History of cardiac disease.
5. Significant impairment of hepatic and/or renal function.
6. Any patient considered to be non compliant.

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)
Patients will recruited through the multi-discplinary motor neuron disease clinical service at the Prince of Wales Hospital and through the Motor Neurone Disease Association of New South Wales.

Allocation concealment will be achieved by contacting the clinical trials pharmacist who holds the allocation schedule. The clinical trials pharmacist is located off-site to where all testing and investigations are conducted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation. Patients will be stratified according to site of disease onset i.e. limb or bulbar-onset.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Lead-in phase prior to treatment phase to calculate pre-treatment rate of change in primary and secondary endpoints. Data will be analysed using a linear mixed effects model.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3580 0
Self funded/Unfunded
Name [1] 3580 0
A/Prof. Matthew Kiernan
Country [1] 3580 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
South Eastern Sydney Illawarra Area Health Service
Address
Prince of Wales Hospital
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 3216 0
Other
Name [1] 3216 0
Motor Neuron Disease Research Institute of Australia
Address [1] 3216 0
PO Box 990 GLADESVILLE NSW 1675
Country [1] 3216 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5622 0
South Eastern Sydney Area Health Service Eastern Section
Ethics committee address [1] 5622 0
Ethics committee country [1] 5622 0
Australia
Date submitted for ethics approval [1] 5622 0
Approval date [1] 5622 0
Ethics approval number [1] 5622 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28740 0
Address 28740 0
Country 28740 0
Phone 28740 0
Fax 28740 0
Email 28740 0
Contact person for public queries
Name 11897 0
A/Prof. Matthew Kiernan
Address 11897 0
Institute of Neurological Sciences
Prince of Wales Hospital
NSW 2031
Country 11897 0
Australia
Phone 11897 0
02 9382 2422
Fax 11897 0
02 9382 2437
Email 11897 0
[email protected]
Contact person for scientific queries
Name 2825 0
A/Prof. Matthew Kiernan
Address 2825 0
Institute of Neurological Sciences
Prince of Wales Hospital
NSW 2031
Country 2825 0
Australia
Phone 2825 0
02 9382 2422
Fax 2825 0
02 9382 2437
Email 2825 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBiomarkers and future targets for development in amyotrophic lateral sclerosis.2014http://dx.doi.org/10.2174/0929867321666140601161148
EmbaseFlecainide in Amyotrophic Lateral Sclerosis as a Neuroprotective Strategy (FANS): A Randomized Placebo-Controlled Trial.2015https://dx.doi.org/10.1016/j.ebiom.2015.11.022
N.B. These documents automatically identified may not have been verified by the study sponsor.