Regeneration in Cervical Degenerative Myelopathy
About this trial
This trial will test whether the drug ibudilast improves recovery in individuals undergoing spinal decompression surgery for Degenerative Cervical Myelopathy (DCM). DCM is a degenerative arthritic condition causing loss of nerve function due to pressure on the spinal cord. Previous studies indicate that ibudilast is safe and may protect spinal cord nerves and promote their recovery. If included in the trial, participants with DCM who are planning to have decompression surgery will be randomly assigned to take either oral ibudilast or a placebo drug beginning up to 10 weeks prior to surgery and continuing for up to 24 weeks after surgery. Researchers will measure changes in motor and sensory function in the upper and lower extremities, bladder emptying function, and neck pain. Questionnaires on health and well-being will also be given. These assessments will be performed periodically before and up to 12 months after surgery. Pre-operative and 6-month post-operative MRI scans of the neck will also be performed.
Included participants
Non-traumatic
Stenosis
What’s involved
Type
Details
Undergo a planned spinal decompression surgery to relieve pressure on the cervical spinal cord. Daily oral dosing of study medication (Ibudilast or placebo) starting up to 10 weeks prior to surgery, and continuing for up to 24 weeks after surgery (total of up to 34 weeks) Participate in study outcome assessments periodically beginning at baseline before surgery to 12 months after surgery.
Potential benefits
Main benefits
Arm/hand function
Additional benefits
Bladder health
Bone health
General health
Mental health
Pain
Sensory function
Standing/walking/mobility
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Recruiting
- Trial start date
- 22 Dec 2021
- Organisation
- Cambridge University Hospitals NHS Foundation Trust
- Trial recruitment status
- Recruiting
- Trial start date
- 22 Dec 2021
- Organisation
- Cambridge University Hospitals NHS Foundation Trust
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more