Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Clemastine fumarate as remyelinating treatment in internuclear ophthalmoparesis and multiple sclerosis (RESTORE)

This important study, called RESTORE, is investigating a medicine called clemastine fumarate. It's designed to see if clemastine can help repair nerve damage in people with multiple sclerosis (MS) or a specific eye movement problem called internuclear ophthalmoparesis. The study will give some participants clemastine and others a dummy pill (placebo) or another existing MS medicine. Researchers will compare how well people's eye movements improve over 6 months and continue to follow them for up to 3 years. This type of study, known as a Phase III trial, is a crucial step towards understanding if a new treatment is safe and effective enough to be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Amsterdam UMC Stichting

Enrolment target

Start

14 Aug 2024

Internuclear ophthalmoparesis, Multiple sclerosis

What is this study about?

This study, called RESTORE, is looking into a medicine named clemastine fumarate. We want to find out if this medicine can help people with multiple sclerosis (MS) or a related condition that affects eye movement, called internuclear ophthalmoparesis. In MS, the protective covering around nerves gets damaged, which can lead to various symptoms. Clemastine is thought to help repair this protective covering, potentially improving symptoms.

We'll be comparing clemastine with a dummy pill (placebo) or another medicine already used for MS called Fampyra. The main thing we'll be looking at is how much eye movement improves. Specifically, we'll measure something called the Versional Dysconjugacy Index (don't worry about the scientific name!) to see if the medicine helps correct eye coordination.

The study will last for 6 months for the main treatment period, but we'll also follow participants for up to 3 years afterwards. This long follow-up helps us understand if the benefits last over time. This is a "Phase III" study, which means it's a large, important step to confirm if a treatment works well and is safe before it can be considered for wider use.

Key takeaways

The study investigates clemastine for MS and an eye movement condition.
It aims to repair nerve damage and improve eye coordination.
Participants will take capsules or tablets over 6 months.
Follow-up will continue for up to 3 years to see long-term effects.
This is a Phase III study, crucial for new treatment approval.
Careful eye movement measurements will assess the treatment's effect.

Who may be eligible?

To join this study, you must be at least 18 years old. People of all genders can take part.

You would need to have been diagnosed with either multiple sclerosis (MS) or internuclear ophthalmoparesis. There will be other specific health requirements that the study doctors will check to make sure the study is a good fit for you and safe.

The research staff will explain all the requirements in detail and answer any questions you have to help you understand if you can join.

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.

Are you 18 years old or older?
Do you have a diagnosis of multiple sclerosis (MS)?
Do you have a diagnosis of internuclear ophthalmoparesis?
Are you able to attend regular clinic visits for up to 3 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the study medicine (clemastine), a dummy pill (placebo), or another approved MS medicine taken as capsules or tablets. The study is "blinded," meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over.

You will have regular visits to the clinic over a 6-month period for assessments. These assessments will involve checking your eye movements carefully and likely other tests like blood samples or questionnaires to see how you are doing. After the main 6-month treatment period, you will have follow-up visits at 12, 24, and 36 months to see if any benefits last for a longer time. The total time you would be involved in follow-up could be up to 3 years.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as closely monitored care and access to a new treatment that could help improve your condition. However, there's no guarantee the treatment will work for everyone, and you might receive a dummy pill. As with all medicines, there could be side effects or risks, which your study team will explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is clemastine fumarate?

It's a medicine being tested to see if it can help repair nerve damage in conditions like multiple sclerosis.

What is internuclear ophthalmoparesis?

It's a condition that affects eye movement, making it hard for your eyes to work together smoothly when looking from side to side.

What does 'Phase III' mean for a study?

It means it's a late-stage study, usually involving many people, to confirm if a new medicine is safe and effective before it might be approved for wider use.

Will I know if I'm getting the real medicine or a dummy pill?

No, neither you nor your study doctor will know this during the study. This helps ensure fair and accurate results.

How long will I be involved in the study?

The main treatment period is 6 months, with follow-up appointments extending your involvement for up to 3 years.