NCT04148781: FAMP-ON

The Effect of Fampridine-SR on Visual Function in Poorly Recovered Optic Neuritis in Persons With MS

Status unknown EARLY_PHASE1 Last updated 22 August 2022

What this trial tests

EARLY_PHASE1 trial testing Fampridine SR in Optic Neuritis in 20 participants. Status unknown.

Timeline

22 March 2022

Primary endpoint
1 December 2023

1 January 2024

Quick facts

Lead sponsor	Courtney Casserly
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	22 March 2022
Primary completion	1 December 2023
Estimated completion	1 January 2024
Sites	1 location across Canada

Drugs / interventions tested

• Fampridine SR

Conditions studied

• Optic Neuritis — all drugs for Optic Neuritis →

Sponsor

Courtney Casserly

Who can join

Adults 18 to 64, any sex, with Optic Neuritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Visual Evoked Potentials
  Time frame: Measured at baseline, week 8, and week 12
  Visual evoked potentials (VEPs) measure the occipital cortical response to visual stimuli and are used to detect visual abnormalities. VEPs will be measured at multiple time points to assess any changes in VEPs over the duration of the study.
• Change in Visual Acuity
  Time frame: Measured at baseline, week 8, and week 12
  Change in visual acuity will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts and standard protocol as it the gold standard for ophthalmology clinical trials using visual acuity as an outcome. Visual acuity will be measured at multiple time points to assess any changes over the duration of the study.
• Change in Contrast Sensitivity
  Time frame: Measured at baseline, week 8, and week 12
  Contrast sensitivity or low contrast visual acuity (LCVA) has been found to be a sensitive measure of visual function in demyelinating lesions when focusing on recovery, even in patients with high contrast visual acuity. Contrast sensitivity will be measured at multiple time points to assess any changes over the duration of the study.
• Change in Colour Vision
  Time frame: Measured at baseline, week 8, and week 12
  Colour vision is frequently affected in optic neuritis and unlikely to fully recover We will use Ishihara colour plates, a common test to assess colour vision. Colour vision will be measured at multiple time points to assess any changes over the duration of the study.
• Change in Visual Fields
  Time frame: Measured at baseline, week 8, and week 12
  Measures of central visual function are important in the evaluation of optic neuritis, because most cases of optic neuritis affect central vision and therefore decrease quality of life. Visual fields will be measured at multiple time points to assess any changes over the duration of the study.
• Optical Coherence Tomography
  Time frame: Measured at baseline.
  Optical coherence tomography (OCT) is now a ubiquitous technology in the world of MS research, and is an excellent means of imaging the layers of the retina.

Sponsor's own description

Optic Neuritis (ON) is a condition that occurs in approximately 50% of individuals with relapse remitting MS, and is the presenting event in 15-20% of patients who go on to develop MS. These ON events present with a decline in vision over several days with painful eye movements. The purpose of this study is to collect pilot data on the effect of Fampridine-SR on the recovery of visual function after demyelinating optic neuritis.Our team evaluated a person with ON who had incomplete recovery which was quite bothersome to her. After a one-month treatment course Fampridine SR,her visual functioning improved. Based on this case, we present a unique opportunity to evaluate the potential benefit of Fampridine-SR as a potential treatment for persons who do not fully recover from acute ON.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.