Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000782639
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
21/07/2014
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Fampyra on visual function following previous optic neuritis.
Scientific title
A Phase IV double blind placebo controlled cross-over study on the effects of Fampyridine on low contrast visual acuity in patients with previous demyelinating optic neuritis.
Secondary ID [1] 284937 0
Nil
Universal Trial Number (UTN)
U1111-1159-0154
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Optic Neuritis 292418 0
Condition category
Condition code
Neurological 292733 292733 0 0
Multiple sclerosis
Eye 292830 292830 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fampridine 10mg po BD for 4 weeks.

Adherence will be monitored by a pill log and drug tablet return.

A phone call review at 2 weeks will assess the pill log, adverse events to try and improve adherence.

A 2 week wash out period will occur between two arms of a cross-over trial design.
Intervention code [1] 289766 0
Treatment: Drugs
Comparator / control treatment
Placebo controlled - 1 microcellulose tablet po BD for 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 292584 0
Binocular low contrast visual acuity
- low contrast Sloan letter chart (100%, 5%, 1.25%, 0.06%)
Timepoint [1] 292584 0
Baseline, and at 4 weeks of study drug.
Secondary outcome [1] 309262 0
P100 latency of qualifying affected eye
- Visual evoked potential obtained measurement completed as per ISCEV standards
Timepoint [1] 309262 0
Baseline, and at 4 weeks of study drug
Secondary outcome [2] 309263 0
Visual quality of life measure by NEI-VFQ25
- total and subscores.
Timepoint [2] 309263 0
Baseline and following 4 weeks of study drug
Secondary outcome [3] 309264 0
Perimetric mean deviation of visual fields
- calculated by Humphries Visual Field testing.
Timepoint [3] 309264 0
Baseline and at 4 weeks of study drug
Secondary outcome [4] 309265 0
Monocular low contrast visual acuity as an experimental outcome
- low constrast Sloan letter charts (100%, 5%, 1.25%, 0.06%)
Timepoint [4] 309265 0
Baseline and following 4 weeks of study drug

Eligibility
Key inclusion criteria
Previous symptomatic monocular optic neuritis in setting of Multiple Sclerosis or other demyelinating optic neuritis

Reduction in binocular low contrast visual acuity as measured by Sloan Letter low contrast visual acuity chart (at least 7 letters on contrast level 0.6%)

Residual prolonged P100 latencies on visual evoked potentials >110ms

Reduction in visual quality of life measure, NEI- VFQ 25:
(total score <90 and one subscale score <90; or 3 subscale scores < 90)

Age 18 y or over

Able to give informed consent

Eligible for Fampyra (fampridine) treatment according to the local label
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of seizures

Renal impairment (CrCl <50ml/min or eGFR <59 ml/min)

Pregnancy or Breast Feeding

High contrast monocular visual acuity in the affected eye worse than 6/15 (20/50).

Visual impairment in the eye not affected by the qualifying episode.

Optic neuritis within the 6 months prior to randomization. Patients who develop optic neuritis during the course of the study will be excluded from analysis.

Other visual diseases affecting measures – glaucoma, cataracts

Clinical diagnosis of Neuromyelitis Optica

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)
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 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 16 has 80% power to detect a difference of 3 letters in low contrast visual acuity, which is well below the difference between those with MS and healthy controls of 7 letters and we expect represents a clinically important difference.
For our most important secondary outcome, visual evoked potentials, a sample size of 16 has 80% power to detect a paired difference of 5 msec using the larger SD. We will recruit 20 subjects for this study to allow for drop outs during the course of the study.

Simple data descriptions including paired t-tests for the outcome at each visit as well as change from baseline will be used. The primary analysis for continuous variables will be mixed linear models with the baseline measurement as a continuous co-variate and a random effect for participant to account for the cross-over design.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2014
Actual
5/12/2015
Date of last participant enrolment
Anticipated
31/10/2014
Actual
20/06/2017
Date of last data collection
Anticipated
Actual
20/06/2017
Sample size
Target
20
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 6203 0
New Zealand
State/province [1] 6203 0
Wellington

Funding & Sponsors
Funding source category [1] 289568 0
Commercial sector/Industry
Name [1] 289568 0
Biogen Idec Australia Pty Ltd
Country [1] 289568 0
Australia
Primary sponsor type
Individual
Name
Jennifer Taylor
Address
Neurology Department
Clinical Measurement Unit
Wellington Hospital
Riddiford Street
PO Box 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 288250 0
Individual
Name [1] 288250 0
Dr Gareth Parry
Address [1] 288250 0
Neurology Department
Clinical Measurement Unit
Wellington Hospital
Riddiford Street
PO Box 7902
Wellington 6242
Country [1] 288250 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291305 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 291305 0
Ethics committee country [1] 291305 0
New Zealand
Date submitted for ethics approval [1] 291305 0
31/07/2014
Approval date [1] 291305 0
04/09/2014
Ethics approval number [1] 291305 0
14/CEN/122

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

Contacts
Principal investigator
Name 49774 0
Dr Jennifer Taylor
Address 49774 0
Neurology Department,
Clinical Measurement Unit,
Wellington Hospital,
PO Box 7902,
Wellington 6242
Country 49774 0
New Zealand
Phone 49774 0
+64 21 211 3867
Fax 49774 0
+64 4 806 0072
Email 49774 0
[email protected]
Contact person for public queries
Name 49775 0
Jennifer Taylor
Address 49775 0
Neurology Department,
Clinical Measurement Unit,
Wellington Hospital,
PO Box 7902,
Wellington 6242
Country 49775 0
New Zealand
Phone 49775 0
+64 21 211 3867
Fax 49775 0
Email 49775 0
[email protected]
Contact person for scientific queries
Name 49776 0
Jennifer Taylor
Address 49776 0
Neurology Department,
Clinical Measurement Unit,
Wellington Hospital,
PO Box 7902,
Wellington 6242
Country 49776 0
New Zealand
Phone 49776 0
+64 21 211 3867
Fax 49776 0
Email 49776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised data of results
When will data be available (start and end dates)?
1/12/2019 - 06/6/2020
Available to whom?
MS and optic neuritis researchers
Available for what types of analyses?
For discussion
How or where can data be obtained?
Contact primary investigator


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
No additional documents have been identified.