Recruiting
Early Phase 1

Fampridine-SR & Optic Neuritis

Sponsor:

Courtney Casserly

Code:

NCT04148781

Conditions

Optic Neuritis

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Fampridine SR

Study Details

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.

Conditions

Optic Neuritis

Study ID

NCT04148781

Start date

Mar 22, 2022

Status verified date

Aug, 2022

Completion date

Jan, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fampridine-SR

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

Interventions

Fampridine SR

Fampridine-SR 10 mg twice daily for 8 weeks

Primary outcome measure

  • Change in Visual Evoked Potentials [ Time Frame: Measured at baseline, week 8, and week 12 ]
  • Change in Visual Acuity [ Time Frame: Measured at baseline, week 8, and week 12 ]
  • Change in Contrast Sensitivity [ Time Frame: Measured at baseline, week 8, and week 12 ]
  • Change in Colour Vision [ Time Frame: Measured at baseline, week 8, and week 12 ]
  • Change in Visual Fields [ Time Frame: Measured at baseline, week 8, and week 12 ]
  • Optical Coherence Tomography [ Time Frame: Measured at baseline. ]
  • Change in 10-Item Neuro-Ophthalmic Supplement total scores [ Time Frame: Measured at baseline, week 8, and week 12 ]

Central Contacts and Locations

Central contacts

Heather Rosehart, BSc

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

Riya Dhillon, BA

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

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Heather Rosehart, BSc

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

Riya Dhillon, BA

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

Principal Investigator:

Courtney Casserly, MD

More Information

Sponsor

Courtney Casserly

Last update posted

Aug 25, 2022

Last verified

Aug, 2022

Keywords

  • Multiple sclerosis
  • Optic Neuritis
  • Fampyra

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Courtney Casserly on 2022-08-25.