Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000800921
Ethics application status
Approved
Date submitted
28/07/2011
Date registered
29/07/2011
Date last updated
1/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Fampridine improve fatigue in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Scientific title
Fampridine treatment to improve fatigue in chronic inflammatory demyelinating polyneuropathy (CIDP).
Secondary ID [1] 262730 0
nil
Universal Trial Number (UTN)
U1111-1123-2297
Trial acronym
FAMP-CIDP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic inflammatory demyelinating polyneuropathy (CIDP). 270439 0
Condition category
Condition code
Neurological 270584 270584 0 0
Other neurological disorders
Inflammatory and Immune System 270585 270585 0 0
Other inflammatory or immune system disorders

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] 267076 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] 269327 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] 269327 0
basline, 4-weekly visits for 28 weeks and (4 weeks post cessation of drug)
Secondary outcome [1] 279380 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] 279380 0
basline, 4-weekly visits for 28 weeks and (4 weeks post cessation of drug)
Secondary outcome [2] 279381 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] 279381 0
basline, 4-weekly visits for 28 weeks and (4 weeks post cessation of drug)
Secondary outcome [3] 279382 0
Timed 25-foot walk test (Goodman et al 2009): to assess speed by the time taken to walk 25 foot.
Timepoint [3] 279382 0
basline, 4-weekly visits for 28 weeks and (4 weeks post cessation of drug)
Secondary outcome [4] 279383 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] 279383 0
basline, 4-weekly visits for 28 weeks and (4 weeks post cessation of drug)
Secondary outcome [5] 279384 0
MRC sum score, assessed as total score and separately for upper and lower limb muscle groups (Kleyweg et al 1991).
Timepoint [5] 279384 0
basline, 4-weekly visits for 28 weeks and (4 weeks post cessation of drug)
Secondary outcome [6] 279385 0
Fatigue, assessed using the validated fatigue severity scale (Krupp et al 1989)
Timepoint [6] 279385 0
basline, 4-weekly visits for 28 weeks and (4 weeks post cessation of drug)

Eligibility
Key inclusion criteria
Definitive diagnosis of CIDP
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.

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?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2011
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)

Funding & Sponsors
Funding source category [1] 267548 0
Commercial sector/Industry
Name [1] 267548 0
Biogen Idec international GmbH.
Country [1] 267548 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] 266587 0
Hospital
Name [1] 266587 0
Prince of Wales Hospital/South Easturn sydney local health network
Address [1] 266587 0
Prince of Wales Hospital, Barker street
Randwick NSW 2031
Country [1] 266587 0
Australia
Other collaborator category [1] 252144 0
Individual
Name [1] 252144 0
Dr Arun Krishnan
Address [1] 252144 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [1] 252144 0
Australia
Other collaborator category [2] 252145 0
Individual
Name [2] 252145 0
Prof Matthew Kiernan
Address [2] 252145 0
University of New south Wales and Institute of Neulogical Sciences, Prince of Wales Hospital, Barker street Randwick NSW 2031
Country [2] 252145 0
Australia
Other collaborator category [3] 252146 0
Individual
Name [3] 252146 0
Dr Cindy Lin
Address [3] 252146 0
University of New south Wales and Institute of Neulogical Sciences, Prince of Wales Hospital, Barker street Randwick NSW 2031
Country [3] 252146 0
Australia
Other collaborator category [4] 252147 0
Individual
Name [4] 252147 0
Dr Andrew Martin
Address [4] 252147 0
NHMRC Clinical Trials Centre Locked Bag 77, Camperdown NSW 1450
Country [4] 252147 0
Australia
Other collaborator category [5] 252148 0
Individual
Name [5] 252148 0
Ms Christine Cormack
Address [5] 252148 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [5] 252148 0
Australia
Other collaborator category [6] 252149 0
Individual
Name [6] 252149 0
Miss Hannah Pickering
Address [6] 252149 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [6] 252149 0
Australia
Other collaborator category [7] 252150 0
Individual
Name [7] 252150 0
Ms Jenna Murray
Address [7] 252150 0
Room 313, Wallace worth building, University of New south Wales, Sydney 2052
Country [7] 252150 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269509 0
South Eastern Sydney Local Health Network
Ethics committee address [1] 269509 0
Ethics committee country [1] 269509 0
Australia
Date submitted for ethics approval [1] 269509 0
Approval date [1] 269509 0
25/05/2011
Ethics approval number [1] 269509 0
1/10/0237

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

Contacts
Principal investigator
Name 32946 0
Address 32946 0
Country 32946 0
Phone 32946 0
Fax 32946 0
Email 32946 0
Contact person for public queries
Name 16193 0
Dr Arun Krishnan
Address 16193 0
Room 313 Wallace Wurth Building
University of New South Wales Randwick NSW
2052
Country 16193 0
Australia
Phone 16193 0
+61 2 9385 2756
Fax 16193 0
+61 2 9385 3484
Email 16193 0
arun.krishnan@unsw.edu.au
Contact person for scientific queries
Name 7121 0
Dr Arun Krishnan
Address 7121 0
Room 313 Wallace Wurth Building
University of New South Wales Randwick NSW
2052
Country 7121 0
Australia
Phone 7121 0
+61 2 9385 2756
Fax 7121 0
+61 2 9385 3484
Email 7121 0
arun.krishnan@unsw.edu.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

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Walking distance was not improved with fampridine ... [More Details]

Documents added automatically
No additional documents have been identified.