Status unknownEarly phase 1Optic neuritisNCT04148781

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

What it measured

Main measures

  • Change in Visual Evoked Potentials

    Measured at baseline, week 8, and week 12

    Myelin repair
  • Change in Visual Acuity

    Measured at baseline, week 8, and week 12

    Vision
  • Change in Contrast Sensitivity

    Measured at baseline, week 8, and week 12

    MRI lesionsVision
  • Change in Colour Vision

    Measured at baseline, week 8, and week 12

    Vision
  • Change in Visual Fields

    Measured at baseline, week 8, and week 12

    VisionQuality of life (reported by participants)
  • Optical Coherence Tomography

    Measured at baseline.

    Retina scans (OCT)
  • Change in 10-Item Neuro-Ophthalmic Supplement total scores

    Measured at baseline, week 8, and week 12

    Quality of life (reported by participants)

Who could take part

Optic neuritis · 18 to 64

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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care Exclusion Criteria: * Have another medical condition that could affect the visual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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Mar 2022

    2. Main results due

      Dec 2023

    3. Finished

      Jan 2024

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