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

Primary Purpose

Optic Neuritis

Status
Recruiting
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Fampridine SR
Sponsored by
Courtney Casserly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring Multiple sclerosis, Optic Neuritis, Fampyra

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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)

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fampridine-SR

Arm Description

Fampridine-SR 10 mg Orally Twice Daily for 8 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2019
Last Updated
August 22, 2022
Sponsor
Courtney Casserly
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1. Study Identification

Unique Protocol Identification Number
NCT04148781
Brief Title
Fampridine-SR and Optic Neuritis Recovery
Acronym
FAMP-ON
Official Title
The Effect of Fampridine-SR on Visual Function in Poorly Recovered Optic Neuritis in Persons With MS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Courtney Casserly

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
Keywords
Multiple sclerosis, Optic Neuritis, Fampyra

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fampridine-SR
Arm Type
Experimental
Arm Description
Fampridine-SR 10 mg Orally Twice Daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Fampridine SR
Intervention Description
Fampridine-SR 10 mg twice daily for 8 weeks
Primary Outcome Measure Information:
Title
Change in Visual Evoked Potentials
Description
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.
Time Frame
Measured at baseline, week 8, and week 12
Title
Change in Visual Acuity
Description
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.
Time Frame
Measured at baseline, week 8, and week 12
Title
Change in Contrast Sensitivity
Description
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.
Time Frame
Measured at baseline, week 8, and week 12
Title
Change in Colour Vision
Description
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.
Time Frame
Measured at baseline, week 8, and week 12
Title
Change in Visual Fields
Description
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.
Time Frame
Measured at baseline, week 8, and week 12
Title
Optical Coherence Tomography
Description
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.
Time Frame
Measured at baseline.
Title
Change in 10-Item Neuro-Ophthalmic Supplement total scores
Description
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.
Time Frame
Measured at baseline, week 8, and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Or ≥20 ms difference in VEP between eyes 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: Benzodiazepines other than every night at bedtime Opioid and opiates other than every night at bedtime 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Rosehart, BSc
Phone
519-685-8500
Ext
34706
Email
heather.rosehart@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Riya Dhillon, BA
Phone
519-685-8500
Ext
37803
Email
riya.dhillon@lhsc.on.ca
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Rosehart, BSc
Phone
519-685-8500
Ext
34706
Email
heather.rosehart@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Riya Dhillon, BA
Phone
519-685-8500
Ext
37803
Email
riya.dhillon@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Courtney Casserly, MD

12. IPD Sharing Statement

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Fampridine-SR and Optic Neuritis Recovery

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