Degenerative (wear and tear arthritis of the spine) Cervical (concerning the neck) Myelopathy
(injury to the spinal cord), DCM, is the most common spinal cord disorder of adulthood. In
DCM, arthritis of the spine causes compression of the spinal cord.
The symptoms of DCM are often mistaken for natural consequences of ageing, including numb and
clumsy hands, loss of coordination, imbalance, bladder and bowel problems. The weakness can
progress to severe paralysis. Every year approximately 4 individuals in 100,000 undergo
surgery for DCM; however, many more individuals are thought to suffer from DCM.
The main treatment for DCM is surgery. The aim of surgery is to create space and remove the
compression of the spinal cord. This is known to prevent further injury. Unfortunately, the
post-operative improvements are often incomplete and many patients remain severely disabled.
Improving outcome after surgery represents an important unmet clinical need.
Clinical and preclinical findings indicate that the drug Ibudilast can stimulate
neuroprotective and regenerative processes in the spinal cord. Ibudilast is well-tolerated
and used to treat asthma and post-stroke dizziness in Japan and is currently being
investigated for use in treating other neurological diseases.
This study will investigate whether daily oral administration of Ibudilast for a maximum of
34 weeks can improve hand function, strength, balance, urinary problems and reduce pain.
The study will initially be conducted at three sites in the UK, with more sites added as
necessary. Individuals between 18-80 years old, diagnosed with DCM and scheduled for an
operation for the first time will be invited to participate in the trial. The study will
entail patient questionnaires and clinical assessments before surgery, shortly after surgery
and 3, 6, and 12 months after surgery. Moreover, patients will undergo MRI scans
pre-operatively and at 6-months postoperatively to determine whether the treatment was
successful.
Phase:
Phase 3
Details
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust