RecruitingPHASE3INTERVENTIONAL

Regeneration in Cervical Degenerative Myelopathy

This study is looking into a new treatment for a common neck condition called Degenerative Cervical Myelopathy (DCM). DCM happens when wear and tear in the neck bones presses on the spinal cord, leading to symptoms like clumsy hands, balance problems, and even bladder issues. While surgery can stop the condition from getting worse, patients often don't fully recover. Researchers want to see if a drug called Ibudilast, taken daily for up to 34 weeks, can improve these symptoms after surgery. Ibudilast has shown promise in helping the spinal cord repair itself. This trial will involve questionnaires, clinical assessments, and MRI scans before and after surgery to check if the drug helps people recover better.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

400

Start

22 Dec 2021

Estimated completion

01 Sep 2026

Myelopathy Spinal Cord Diseases

What is this study about?

Degenerative Cervical Myelopathy (DCM) is a common condition where the normal wear and tear in your neck and spine leads to pressure on your spinal cord. This pressure can cause a range of symptoms, including numbness, weakness, clumsiness in your hands, difficulty with balance, and sometimes even problems with your bladder or bowels. These symptoms can sometimes be mistaken for general ageing, but they can significantly impact your daily life and, if left untreated, can lead to severe disability.

The main treatment for DCM is an operation to relieve the pressure on the spinal cord. This surgery is very effective at stopping the condition from getting worse, but unfortunately, many people find that their symptoms don't completely go away afterward. There's a real need for treatments that can help people recover more fully and improve their quality of life after surgery.

This study is investigating whether a drug called Ibudilast could help the spinal cord heal and regenerate after surgery for DCM. Ibudilast has been used for other conditions in some countries and has shown potential in laboratory studies to encourage nerve repair. The research team wants to see if taking this medication can lead to better recovery of hand function, strength, balance, and help reduce pain for people with DCM after their operation.

Key takeaways

DCM is a common neck condition affecting the spinal cord.
Surgery helps stop DCM from worsening, but recovery can be incomplete.
This study explores if Ibudilast can improve recovery after DCM surgery.
Participation involves taking daily medication (or placebo) and attending follow-up checks.
The study aims to improve long-term outcomes for DCM patients.

Who may be eligible?

You might be able to take part in this study if you are between 18 and 80 years old and have been diagnosed with Degenerative Cervical Myelopathy (DCM). You'll also need to be scheduled for your first-ever operation for DCM as part of your usual care through the NHS.

There are certain reasons why you might not be able to participate. For example, if you've had surgery for DCM before, or if your DCM symptoms are due to a neck injury. Other health conditions like severe liver problems, certain cancers within the last five years, or specific heart conditions would also mean you couldn't join. Women who are pregnant, breastfeeding, or planning a pregnancy during the study, or those unwilling to use reliable contraception, would also be excluded. You also can't be taking part in another clinical trial at the same time or have taken part in one in the past 30 days.

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 between 18 and 80 years old?
Do you have a diagnosis of Degenerative Cervical Myelopathy (DCM)?
Are you scheduled for your very first surgery for DCM?
Do you not have a history of certain severe liver or heart conditions?
Are you not currently pregnant, breastfeeding, or planning a pregnancy during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to take Ibudilast or a matching placebo (a dummy pill, which looks the same but contains no active drug) every day for up to 34 weeks. You won't know whether you are taking the active drug or the placebo, and neither will your doctors on the study.

Your participation will involve several visits to the study clinic. You'll have assessments before your surgery, shortly after, and again at 3, 6, and 12 months post-surgery. These assessments will include filling out questionnaires about your symptoms and daily life, as well as clinical tests to measure your hand function, strength, balance, and to check for any urinary problems and pain. You will also have MRI scans before your operation and at 6 months after surgery. The total duration of your active involvement in the study will be about a year.

Potential risks and benefits

Participating in this study might offer the potential benefit of improved recovery from your DCM symptoms after surgery, especially if you receive the active drug. However, as with any medication, there's a possibility of side effects, which will be carefully monitored. The drug Ibudilast is generally well-tolerated, but all potential risks will be thoroughly explained to you. You are free 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.

Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is Degenerative Cervical Myelopathy (DCM)?

DCM is a condition where wear and tear in your neck causes pressure on your spinal cord, leading to symptoms like clumsy hands, balance issues, and pain.

What is Ibudilast?

Ibudilast is a drug that the study hopes will help the spinal cord repair itself after surgery for DCM.

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

No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you are receiving Ibudilast or the placebo.

What kind of tests will I have?

You'll complete questionnaires, undergo physical assessments of your strength and balance, and have MRI scans before and after your surgery.

How long will my involvement in the study last?

Your active participation in the study will last for approximately 12 months after your surgery.

How to find out more

Mark R Kotter, PhD

mrk25@cam.ac.uk +44 1223 747476 Official trial record

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