Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000799954
Ethics application status
Approved
Date submitted
28/07/2011
Date registered
29/07/2011
Date last updated
5/03/2021
Date data sharing statement initially provided
5/03/2021
Date results information initially provided
5/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Fampridine improve fatigue in patients with Multiple Sclerosis.
Scientific title
Fampridine treatment to improve fatigue in Multiple Sclerosis.
Secondary ID [1] 262732 0
nil
Universal Trial Number (UTN)
U1111-1123-2297
Trial acronym
FAMP-MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis. 270441 0
Condition category
Condition code
Neurological 270587 270587 0 0
Multiple sclerosis
Inflammatory and Immune System 270588 270588 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fampridine- PR
Oral tablet, 10mg twice daily for a period of 12 weeks.

The study is a double-blind placebo-controlled crossover study, with patients receiving 12 weeks of active drug and 12 weeks of placebo, separated by a 4-week washout period.
Intervention code [1] 267079 0
Treatment: Drugs
Comparator / control treatment
Placebo
Glucose tablet identical in taste and appearance to the active drug.
Control group
Placebo

Outcomes
Primary outcome [1] 269329 0
Six-minute walk test: a validated measure that has been used to assess functional capacity in neuromuscular disease (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories 2002; Kierkegaard & Tollback 2007; McDonald et al 2010). In this setting, it is viewed as a measure of activity-dependent fatigue in patients with demyelinating disease (Goldman et al 2008).
Timepoint [1] 269329 0
basline, 4-weekly visits for 28 weeks and 4 weeks post cessation of drug
Secondary outcome [1] 279389 0
Peripheral nerve excitability measurement (composite score of hyperpolarizing threshold electrotonus at 90-100ms, late subexcitability, refractoriness and superexcitability), including pre/post voluntary contraction studies.
Timepoint [1] 279389 0
basline, 4-weekly visits for 28 weeks and 4 weeks post cessation of drug
Secondary outcome [2] 279390 0
Handgrip dynamometry: to assess maximum grip strength as the strongest of 3 contractions in each hand. Fatigability will be assessed as the sum of results of 15 consecutive contractions.
Timepoint [2] 279390 0
basline, 4-weekly visits for 28 weeks and 4 weeks post cessation of drug
Secondary outcome [3] 279391 0
Timed 25-foot walk test (Goodman et al 2009): to assess speed by the time taken to walk 25 foot.
Timepoint [3] 279391 0
basline, 4-weekly visits for 28 weeks and 4 weeks post cessation of drug
Secondary outcome [4] 279392 0
Nine-hole pegboard test:to assess the time taken to complete a dexterity task which requires the subject to put 9 pegs in 9 holes and then remove them.
Timepoint [4] 279392 0
basline, 4-weekly visits for 28 weeks and 4 weeks post cessation of drug
Secondary outcome [5] 279393 0
MRC sum score, assessed as total score and separately for upper and lower limb muscle groups (Kleyweg et al 1991).
Timepoint [5] 279393 0
basline, 4-weekly visits for 28 weeks and 4 weeks post cessation of drug
Secondary outcome [6] 279394 0
Fatigue, assessed using the validated fatigue severity scale (Krupp et al 1989)
Timepoint [6] 279394 0
basline, 4-weekly visits for 28 weeks and 4 weeks post cessation of drug

Eligibility
Key inclusion criteria
Definitive diagnosis of MS
18-80 years of age.
Able to provide informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of seizures.
Current treatment with anticonvulsant medication.
Pregnancy or lactation. Contraception is required in pre-menopausal female patients.
History of moderate-severe renal impairment.
Presence of serious psychiatric disorder (e.g major depression, bipolar disorder)
Enrolled in another clinical trial involving an investigational agent.
Known allergy to pyridine-containing substances.
History of renal dysfunction, with eGFR <60 ml.
history of acute relapse within last 60 days
EDSS score >6.0

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)
Random sampling undertaken by Prince of Wales Clinical Trials Pharmacy in association with NHMRC Clinical Trials Center.
Allocation involved contacting the holder of the allocation schedule who was at central administration site namely Prince of Wales Clinical Trials Pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study is a double-blind placebo-controlled crossover study, with patients receiving 12 weeks of active drug and 12 weeks of placebo, separated by a 4-week washout period.

Random sampling undertaken by Prince of Wales Clinical Trials Pharmacy in association with NHMRC Clinical Trials Center. Simple randomisation using a randomisation table created by computer software.
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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2011
Actual
15/08/2011
Date of last participant enrolment
Anticipated
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
31/10/2013
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18863 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 33364 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 267549 0
Commercial sector/Industry
Name [1] 267549 0
Biogen Idec international GmbH.
Country [1] 267549 0
Switzerland
Primary sponsor type
University
Name
Univeristy of New South Wales
Address
Gate 9, High St
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 266588 0
Hospital
Name [1] 266588 0
Prince of Wales Hospital/South Easturn sydney local health network
Address [1] 266588 0
Prince of Wales Hospital, Barker street
Randwick NSW 2031
Country [1] 266588 0
Australia
Other collaborator category [1] 252151 0
Individual
Name [1] 252151 0
Dr Arun Krishnan
Address [1] 252151 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [1] 252151 0
Australia
Other collaborator category [2] 252152 0
Individual
Name [2] 252152 0
Prof Matthew Kiernan
Address [2] 252152 0
University of New south Wales and Institute of Neulogical Sciences, Prince of Wales Hospital, Barker street Randwick NSW 2031
Country [2] 252152 0
Australia
Other collaborator category [3] 252153 0
Individual
Name [3] 252153 0
Dr Cindy Lin
Address [3] 252153 0
University of New south Wales and Institute of Neulogical Sciences, Prince of Wales Hospital, Barker street Randwick NSW 2031
Country [3] 252153 0
Australia
Other collaborator category [4] 252154 0
Individual
Name [4] 252154 0
Dr Andrew Martin
Address [4] 252154 0
NHMRC Clinical Trials Centre Locked Bag 77, Camperdown NSW 1450
Country [4] 252154 0
Australia
Other collaborator category [5] 252155 0
Individual
Name [5] 252155 0
Ms Christine Cormack
Address [5] 252155 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [5] 252155 0
Australia
Other collaborator category [6] 252156 0
Individual
Name [6] 252156 0
Miss Hannah Pickering
Address [6] 252156 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [6] 252156 0
Australia
Other collaborator category [7] 252157 0
Individual
Name [7] 252157 0
Ms Jenna Murray
Address [7] 252157 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [7] 252157 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269511 0
South Eastern Sydney Local Health Network
Ethics committee address [1] 269511 0
Room G71, East Wing
Edmund Blackette Building
Prince of Wales Hospital
High Street Randwick NSW 2031
Ethics committee country [1] 269511 0
Australia
Date submitted for ethics approval [1] 269511 0
Approval date [1] 269511 0
25/05/2011
Ethics approval number [1] 269511 0
1/10/0237

Summary
Brief summary
The purpose is to investigate whether treatment with the medication, fampridine, can help improve the ability to function in patients who have Multiple Sclerosis.

Who is this for?
You are eligible to participate in this study if you are ages between 18-80, have Multiple Sclerosis and currently suffer from fatigue and a decreased functional ability.

Trial detials
In this studywith patients will receiving 12 weeks of Fampridine (active drug) at a dose of 10mg oral tablet twice daily, and 12 weeks of placebo (sham) treatment consisting of lacotse tablets, separated by a 4-week washout period.
During the trial, participants will not know if they are receiving active drug or the placebo.

Participants will be assessed at basline foloowed by 4 weekly intervals to measure fatigue, functional ability and nerve function.
Trial website
Trial related presentations / publications
Lin CSY, Krishnan AV, Park SB, Kiernan MC (2011). Modulatory effects on axonal function following intravenous immunoglobulin in CIDP. Annals of Neurology. 68(7):862-896.
Public notes

Contacts
Principal investigator
Name 32949 0
Prof Arun Krishnan
Address 32949 0
Department of Neurology, Prince of Wales Hospital, Randwick
Country 32949 0
Australia
Phone 32949 0
+61 93822414
Fax 32949 0
Email 32949 0
[email protected]
Contact person for public queries
Name 16196 0
Dr Arun Krishnan
Address 16196 0
Room 313 Wallace Wurth Building
University of New South Wales Randwick NSW
2052
Country 16196 0
Australia
Phone 16196 0
+61 2 9385 2756
Fax 16196 0
+61 2 9385 3484
Email 16196 0
[email protected]
Contact person for scientific queries
Name 7124 0
Dr Arun Krishnan
Address 7124 0
Room 313 Wallace Wurth Building
University of New South Wales Randwick NSW
2052
Country 7124 0
Australia
Phone 7124 0
+61 2 9385 2756
Fax 7124 0
+61 2 9385 3484
Email 7124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot study, group level outcomes


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Clinical Neurophysiology 128 (2017) 93–99 343271-(Uploaded-05-07-2020-09-33-22)-Journal results publication.pdf
Plain language summaryNo Fampridine treatment improved walking distance.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFampridine treatment and walking distance in multiple sclerosis: A randomised controlled trial.2017https://dx.doi.org/10.1016/j.clinph.2016.10.088
N.B. These documents automatically identified may not have been verified by the study sponsor.