Regeneration in Cervical Degenerative Myelopathy - a Multi-centre, Double-blind, Randomised, Placebo Controlled Trial Assessing the Efficacy of Ibudilast as an Adjuvant Treatment to Decompressive Surgery for Degenerative Cervical Myelopathy

Who is this study for? Patients with degenerative cervical myelopathy
What treatments are being studied? Ibudilast+Cervical decompressive surgery
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients suffering from degenerative cervical myelopathy as per established criteria who have granted informed consent to participate in the trial

• Have a preoperative mJOA score ≥8 and ≤14

• Scheduled for first surgical decompression as part of usual NHS clinical practice

Locations
Other Locations
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
Contact Information
Primary
Mark R Kotter, PhD
mrk25@cam.ac.uk
+44 1223 747476
Backup
Paula Kareclas, PhD
paula.kareclas@addenbrookes.nhs.uk
01223254684
Time Frame
Start Date: 2021-12-22
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 400
Treatments
Active_comparator: Ibudilast
Increasing dose of Ibudilast up to 100mg/day for up to 10 weeks prior to cervical decompressive surgery and up to 24 weeks after cervical decompressive surgery
Placebo_comparator: Placebo
Increasing dose of matched placebo containing mannitol instead of ibudilast up to 10 pills/day for up to 10 weeks prior to cervical decompressive surgery and up to 24 weeks after cervical decompressive surgery
Related Therapeutic Areas
Sponsors
Leads: Cambridge University Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov