The effect of Fampyra on visual function following previous optic neuritis.

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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000782639

Enrollment

Registered

2014-07-21

Start date

2015-12-05

Completion date

2017-06-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results