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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
Universal Trial Number (UTN)
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 4
Type of endpoint(s)
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 status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6203 0
New Zealand
State/province [1] 6203 0

Funding & Sponsors
Funding source category [1] 289568 0
Commercial sector/Industry
Name [1] 289568 0
Biogen Idec Australia Pty Ltd
Address [1] 289568 0
Suite 1, Level 5, 123 Epping Road
North Ryde
Australia 2113
Country [1] 289568 0
Primary sponsor type
Jennifer Taylor
Neurology Department
Clinical Measurement Unit
Wellington Hospital
Riddiford Street
PO Box 7902
Wellington 6242
New Zealand
Secondary sponsor category [1] 288250 0
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
Ethics committee name [1] 291305 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 291305 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 291305 0
New Zealand
Date submitted for ethics approval [1] 291305 0
Approval date [1] 291305 0
Ethics approval number [1] 291305 0

Brief summary
Optic neuritis is a condition where optic nerve inflammation occurs leading to reduced visual function. It is a common presenting episode of multiple sclerosis, and many patients with multiple sclerosis will have had optic neuritis through the course of their disease. Whilst high contrast visual acuity generally recovers well months following the event, there is evidence of under-recognised visual dysfunction in patients with previous optic neuritis, as well as Multiple Sclerosis, using other measures such as low contrast visual acuity and vision related quality of life measures.

Fampyra is a potassium channel blocker which as been proven to improve walking speed in Multiple Sclerosis, as a symptomatic treatment. It's benefit is thought to be due to restoration of nerve conduction in unmyelinated nerves.

Our plan is to test whether Fampyra can provide benefits on visual function in those patients with a previous episode of optic neuritis, and measures of visual dysfunction on screening investigations. The study will employ a randomised cross over placebo controlled study design, with 20 patients undergoing assessments around a 2 stage study, with Drug A and then Drug B given for a four week period, with a 2 week washout period.

Visual assessments will be undertaken at baseline, and at 4 weeks on the study drug to look for change in function. Assessments will include low contrast visual acuity, vision related quality of life measure (NEI-VFQ25), visual evoked potentials (a electrophysiological marker of optic nerve conduction), and visual field testing.

Trial website
Trial related presentations / publications
Public notes

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
Contact person for public queries
Name 49775 0
Dr 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
Contact person for scientific queries
Name 49776 0
Dr 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary