NCT04148781

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

September 11, 2019

Last Update Submit

August 22, 2022

Conditions

Optic Neuritis

Keywords

Multiple sclerosisOptic NeuritisFampyra

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

Fampridine-SR

EXPERIMENTAL

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

Drug: Fampridine SR

Interventions

Fampridine SRDRUG

Fampridine-SR 10 mg twice daily for 8 weeks

Fampridine-SR

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Optic NeuritisMultiple Sclerosis

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Heather Rosehart, BSc

CONTACT

519-685-8500heather.rosehart@lhsc.on.ca

Riya Dhillon, BA

CONTACT

519-685-8500riya.dhillon@lhsc.on.ca

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

September 11, 2019

First Posted

November 4, 2019

Study Start

March 22, 2022

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

CA(1)