Fampridine-SR and Optic Neuritis Recovery (FAMP-ON)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Optic Neuritis
• Intervention / Treatment: Drug: Fampridine SR

Detailed 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. ON usually presents with a decline in vision over several days to weeks with painful eye movements.

Fampridine-SR is currently a Health Canada approved medication to treat walking impairment in persons with MS. Some small studies in the past have shown that Fampridine-SR may also have positive effects on visual functioning in those experiencing ON.

This study will aim to assess the effect of taking Fampridine-SR for 8 weeks in 20 MS patients with unresolved optic neuritis on measures of visual functioning, and to determine the best measures to use in a future large scale study. The results of this study will also be used to estimate how many participants we will need in the future large scale study.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Heather Rosehart, BSc; Phone Number: 34706 519-685-8500; Email: heather.rosehart@lhsc.on.ca
• Study Contact Backup: Name: Riya Dhillon, BA; Phone Number: 37803 519-685-8500; Email: riya.dhillon@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Sciences Centre
      • Contact: Heather Rosehart, BSc; Phone Number: 34706 519-685-8500; Email: heather.rosehart@lhsc.on.ca
      • Contact: Riya Dhillon, BA; Phone Number: 37803 519-685-8500; Email: riya.dhillon@lhsc.on.ca
      • Principal Investigator: Courtney Casserly, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have an MS diagnosis, any type
• Had an acute optic neuritis without full recovery which occurred ≥ one year ago

• Have a visual acuity in the affected of eye of ≥ 20/40 or

  1. Or ≥20 ms difference in VEP between eyes
  2. Or ≥ 120 ms VEP in the affected eye
• Have not received corticosteroids in the last thirty (30) days

• Medications that could potentially affect the VEP P100 amplitude or may cause drowsiness/difficulty with visual fixation are allowed if there has been no change in dose within 30 days of study enrollment or anytime during the study. These medications include:

  1. Benzodiazepines other than every night at bedtime
  2. Opioid and opiates other than every night at bedtime
  3. Cannabinoid products other than every night at bedtime
• Have given written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care

Exclusion Criteria:

• Have another medical condition that could affect the visual outcomes, such as, but not limited to, diabetes retinopathy, glaucoma, cataracts, previous ocular trauma, amblyopia, and optic neuropathy not due to a demyelinating lesion
• Creatinine clearance ≤ 80 mL/min
• Has a history of seizures, with the exception of febrile seizure as an infant
• Taking a medicinal product that is an inhibitor of Organic Cation Transporter 2 (OCT-2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fampridine-SR; Fampridine-SR 10 mg Orally Twice Daily for 8 weeks.	Drug: Fampridine SR; Fampridine-SR 10 mg twice daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Evoked Potentials	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.	Measured at baseline, week 8, and week 12
Change in Visual Acuity	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.	Measured at baseline, week 8, and week 12
Change in Contrast Sensitivity	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.	Measured at baseline, week 8, and week 12
Change in Colour Vision	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.	Measured at baseline, week 8, and week 12
Change in Visual Fields	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.	Measured at baseline, week 8, and week 12
Optical Coherence Tomography	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.	Measured at baseline.
Change in 10-Item Neuro-Ophthalmic Supplement total scores	The 10-Item Neuro-Ophthalmic Supplement (NOS-10) has been developed to capture patient-reported outcomes related to visual dysfunction in patients with visual disorders. Total scores will be collected (range 1 to 52). Scores on the NOS-10 will be measured at multiple time points to assess any changes over the duration of the study.	Measured at baseline, week 8, and week 12

Collaborators and Investigators

• Sponsor: Courtney Casserly

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Optic Neuritis; Fampyra
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Neuritis; Optic Neuritis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Potassium Channel Blockers; 4-Aminopyridine
• Other Study ID Numbers: 113427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No