What side effects are associated with this type of intervention?

Common treatments for Optic Neuritis include corticosteroids and immunosuppressive agents. Corticosteroids can cause side effects such as weight gain, hyperglycemia, and increased risk of infections. Immunosuppressive agents like methotrexate and azathioprine may lead to bone marrow suppression, liver toxicity, and increased susceptibility to infections. Fampridine-SR, a potassium channel blocker, has shown potential in improving visual function in patients with incomplete recovery from Optic Neuritis, but specific side effects are not well-documented in the context provided. Generally, potassium channel blockers can cause side effects such as dizziness, insomnia, and balance issues.

What prior FDA approvals exist?

The primary treatments for optic neuritis have traditionally included high-dose corticosteroids, such as intravenous methylprednisolone, which accelerate recovery but do not affect long-term visual outcomes. There is no specific mention of FDA-approved potassium channel blockers like Fampridine-SR for optic neuritis in the provided context. Fampridine-SR, known for improving walking in multiple sclerosis patients, is being studied for its potential benefits in optic neuritis recovery, but it is not yet an established treatment for this condition.

What other types of research exist?

Currently, there are no specific novel alternatives to Fampridine-SR mentioned for the treatment of Optic Neuritis in the provided context. Fampridine-SR has shown potential in improving visual function in ON patients. For 2024, patients should discuss with their doctors the latest clinical trials and emerging therapies targeting demyelination and neuroprotection, as these areas are actively researched.

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Potassium Channel Blocker

Fampridine for Optic Neuritis (FAMP-ON Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Optic Neuritis include high-dose intravenous corticosteroids and potassium channel blockers like Fampridine-SR. Corticosteroids work by reducing inflammation and immune response, which can help speed up the recovery of vision by decreasing the swelling and damage to the optic nerve. Fampridine-SR, a potassium channel blocker, improves nerve signal conduction by blocking potassium channels on demyelinated nerves, which can enhance visual function and overall neurological performance. These mechanisms are crucial for Optic Neuritis patients as they directly address the inflammation and impaired nerve conduction that characterize the condition, potentially leading to faster and more complete recovery of visual function.

Phase < 1

Waitlist Available

Research Sponsored by Courtney Casserly

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, week 8, and week 12

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a medication called Fampridine-SR on MS patients who haven't fully recovered their vision after optic neuritis. The goal is to see if it can improve their vision by helping nerves send signals better. Fampridine-SR is primarily used to improve walking ability in MS patients.

Who is the study for?

This trial is for individuals who have had optic neuritis (ON) at least a year ago without full recovery. They should have certain visual acuity or visual evoked potential (VEP) differences, no recent corticosteroids use, and stable doses of some medications. Participants must not have seizures history (except infant febrile seizure), take OCT-2 inhibitors, or other conditions affecting vision like diabetes retinopathy.

What is being tested?

The study tests Fampridine-SR's effect on improving visual function after demyelinating ON based on promising results from a previous case where it helped with vision recovery. It aims to gather initial data to see if this could be an effective treatment for those who don't fully recover from acute ON.

What are the potential side effects?

While the specific side effects are not listed here, Fampridine-SR may cause similar side effects as in its general use: dizziness, trouble sleeping, nausea, headache, weakness and potential risk of seizures especially in those predisposed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, week 8, and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, week 8, and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, week 8, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 10-Item Neuro-Ophthalmic Supplement total scores

Change in Colour Vision

Change in Contrast Sensitivity

+4 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fampridine-SRExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dalfampridine

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Optic Neuritis include high-dose intravenous corticosteroids and potassium channel blockers like Fampridine-SR. Corticosteroids work by reducing inflammation and immune response, which can help speed up the recovery of vision by decreasing the swelling and damage to the optic nerve. Fampridine-SR, a potassium channel blocker, improves nerve signal conduction by blocking potassium channels on demyelinated nerves, which can enhance visual function and overall neurological performance. These mechanisms are crucial for Optic Neuritis patients as they directly address the inflammation and impaired nerve conduction that characterize the condition, potentially leading to faster and more complete recovery of visual function.

Optic nerve involvement in immunoglobulin G4-related disease: A case report.Should patients with optic neuritis be treated with steroids?Management of acute optic neuritis: a survey of neurologists and ophthalmologists in Australia and New Zealand.