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RecruitingPhase IIInterventional

Nimodipine for acute optic neuritis

This study is exploring a new way to treat acute optic neuritis, a condition where swelling in the eye's optic nerve can lead to vision problems. We're testing a drug called Nimodipine. This drug is already used for other conditions and is generally considered safe with few side effects. We hope it might help by improving blood flow to the optic nerve. Currently, treatments like steroids only help speed up recovery, but don't offer long-term benefits. This study aims to see if Nimodipine can improve vision and if it is safe to use for optic neuritis. Your participation could help us learn more about better treatments for this condition in the future.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
University College London
Enrolment target
15
Start
09 Feb 2026
Estimated completion
01 Jan 2027

What is this study about?

Optic neuritis is a condition that affects your eye, specifically the nerve that connects your eye to your brain, called the optic nerve. When this nerve becomes swollen, it can lead to vision loss. This often happens alongside other conditions, like multiple sclerosis, and currently, the main treatment involves steroids, which can help you recover faster but don't offer long-term improvements or prevent future problems.

Researchers think that as well as swelling, a lack of oxygen and blood flow to the optic nerve might also be causing damage. This study is looking at a drug called Nimodipine. This medication is already widely used and known to be safe, with few side effects. It works by increasing blood flow, and we wonder if it could help the optic nerve get the oxygen it needs to heal.

Our goal is to see if Nimodipine can improve vision for people with new (acute) optic neuritis. We also want to make sure it's safe and well-tolerated. Even if it doesn't directly help you, the information we gather from this study could be very important for developing better treatments for optic neuritis in the future.

Key takeaways

  • This study explores if Nimodipine, a blood-flow improving drug, can help acute optic neuritis.
  • It aims to see if Nimodipine can improve vision and if it is safe and well-tolerated.
  • Participation involves a single 3-hour hospital visit, with a follow-up phone call next day.
  • Risks are generally low, with mild side effects being rare and close monitoring provided.
  • Even if it doesn't directly help you, the study could lead to better treatments for others.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for two groups of people: those who have recently developed optic neuritis and healthy people who will serve as a comparison group and won't receive the study drug.

If you have optic neuritis, you might be able to join if you are between 18 and 60 years old and have been diagnosed with optic neuritis in one eye within the last two weeks. You'll also need to have certain test results that confirm the optic nerve is affected and that your retina (the back of your eye) is otherwise healthy. For women who could become pregnant, special contraceptive rules apply during and shortly after the study because we don't have enough information about the drug's effects during pregnancy.

People who test positive for certain antibodies (AQP4 or MOG) that can cause similar conditions will be excluded from the main analysis, though they will still be followed for safety. The research team will review your medical history and conduct examinations to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 60 years old?
  2. Have you been diagnosed with optic neuritis in one eye less than two weeks ago?
  3. Are you able to visit University College London, UK?
  4. For women, are you willing to use highly effective contraception during the study period?
  5. Are you willing and able to give your informed consent?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some assessments. If you have optic neuritis, you'll then be given a single 60 mg dose of Nimodipine by mouth. All study participants will stay at the hospital for about 3 hours. During this time, we will perform tests to check your vision and watch carefully for any side effects you might experience. If you have optic neuritis, a researcher will call you the next day to check on your well-being.

Being part of the study also involves some routine medical checks such as blood tests, a neurological exam, and eye exams including a special test called an electroretinogram (ERG) and OCT scans. These help us understand your vision and general health. The total time you'll be actively involved in the study is mainly during the initial 3-hour hospital visit, with a follow-up phone call the next day.

Potential risks and benefits

It's important to know that we don't know for sure if taking part in this study will improve your own condition. However, the information we learn might help other people with optic neuritis in the future. The main risks come from the study drug, Nimodipine, though it's generally safe and you'll only receive one dose. Common side effects like nausea or headaches are rare, but more serious ones like allergic reactions or changes in blood pressure, although very rare, are possible. We will monitor you closely during and after the study drug is given. There are also very small risks from study procedures like blood tests or eye exams, such as bruising or temporary discomfort. If you are female and able to have children, you must follow strict contraception rules because the drug might harm an unborn baby. You are free to withdraw from the study at any time without giving a reason, and this will not affect your standard medical care.

Locations (2)

  • National Hospital for Neurology & Neurosurgery - Queen Square
    City only
    London, England
  • Moorfields Eye Hospital
    Approximate
    London, England

Common questions

What is Nimodipine?

Nimodipine is a drug that helps increase blood flow. It's already used for other brain conditions and is generally considered safe with few side effects.

What is optic neuritis?

Optic neuritis is a condition where the nerve connecting your eye to your brain (the optic nerve) becomes inflamed, which can cause vision loss.

Will I get paid for participating?

Yes, you will receive payment to cover your travel and food expenses for taking part in the study.

How long will I be at the hospital?

You will need to stay at the hospital for approximately 3 hours for assessments and to be monitored after receiving the study drug.

Can I stop participating at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Olivia Fox

Always speak to your GP or specialist before deciding to take part in a study.

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