Regeneration in Cervical Degenerative Myelopathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCambridge University Hospitals NHS Foundation Trust
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous surgery for DCM
DCM symptoms due to cervical trauma (at the discretion of the investigator)
Hypersensitivity to Ibudilast or any of the formulation components
Evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation including ALP> 1.5x ULN; ALT or AST > 2x ULN; GGT > 3x ULN
Trial design
Design model
Parallel
Treatments tested in this trial
Ibudilast
DrugIncreasing dose of ibudilast from 60mg/6 capsules per day to 100mg/10 capsules per day to be started up to 10 weeks prior to surgery. Treatment will continue up to 24 weeks after surgery. Maximum treatment period will be of 34 weeks.
Cervical decompressive surgery
Procedure/SurgerySurgical decompression of degenerate cervical myelopathy
Matching placebo
DrugIncreasing dose of matching placebo from 6 capsules per day to 10 capsules per day to be started up to 10 weeks prior to surgery. Treatment will continue up to 24 weeks after surgery. Maximum treatment period will be of 34 weeks.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: IbudilastActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in modified Japanese Orthopaedic Association (mJOA) scale
The mJOA is an 18-point clinician administered scale (0 worst to 18 best), which evaluates motor dysfunction in upper and lower extremities, loss of sensation and sphincter dysfunction.
Time frame
From baseline to 6 months follow-up2
Change in Visual Analogue Scale (VAS) neck pain
VAS Neck pain is a 10cm horizontal line, on which a patient indicates their level of neck pain from 0 (no pain) to 10 (worst pain).
Time frame
From baseline to 6 months follow-upSecondary outcomes
1
PCS-SF36
SF-36 is a health and well-being questionnaire in which patient answers 36 multiple choice questions grouped under 11 sections. The answers to those questions are used to obtain the Physical Component Summary (PCS) of the SF-36 were lower scores indicate worse condition and higher score indicate better condition.
Time frame
From baseline to 6 months follow-up2
MCS-SF36
SF-36 is a health and well-being questionnaire in which patient answers 36 multiple choice questions grouped under 11 sections. The answers to those questions are used to obtain the Mental Component Summary (MCS) of the SF-36 were lower scores indicate worse condition and higher score indicate better condition.
Time frame
From baseline to 6 months follow-upSponsors and contacts
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Source ClinicalTrials.gov