Degenerative Cervical Myelopathy
Conditions
Interventions
Product Name: Ibudilast
Product Code: N/A
Pharmaceutical Form: Capsule
INN or Proposed INN: Ibudilast 10 mg: The Japanese Pharmacopoeia (JP)
CAS Number: 50847-11-5
Current Sponsor code: Ibudilast
Othe
Medicinova MN-166
Vichang
KC-404
Pinatos
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 60-100
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female, ages 18 to 80 years who have granted informed consent to participate • Patients suffering from Degenerative Cervical Myelopathy • Have a preoperative mJOA score =8 and =14 • Scheduled for first surgical decompression as part of usual clinical practice Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 217 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 145
Exclusion criteria
Exclusion criteria: • 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 • Evidence of thrombocytopenia at screening through laboratory evaluation including platelet count 450 ms • History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the investigator to interfere with absorption, distribution, metabolism, or excretion of IMP • Unable to converse, read or write English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this trial is to estimate the difference in the modified Japanese Orthopaedic Association (mJOA) score and the Visual Analogue Scale (VAS) neck pain at 6 months after surgery between Degenerative Cervical Myelopathy (DCM) patients randomised to Ibudilast and those randomised to placebo. The mJOA is a fully validated outcome assessment for function in DCM. The VAS is the most popular tool for the measurement of pain in DCM. The hypothesis is that Ibudilast improves neurological recovery following surgical decompression of DCM.;Secondary Objective: 1) To compare the clinical efficacy of Ibudilast treatment at 3, 6 and 12 months after surgery, using a representative range of DCM outcome assessments The exploratory objectives include: 1) To undertake a health economic evaluation of Ibudilast therapy 2) To assess the bioavailability of Ibudilast in the CSF and blood. 3) To assess the informal care burden of DCM 4) To assess the potential of novel quantitative clinical assessments (Gait Laboratory) ;Primary end point(s): The primary outcome measures are the change in the modified Japanese Orthopaedic Association Score (mJOA) and the change in Visual Analogue Scale (VAS) neck pain between screening and 6 months post-operatively. 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. The 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). ;Timepoint(s) of evaluation of this end point: The primary outcome will be evaluated as the difference in these parameters between baseline (screening visit) and 6-months post-operatively (±21 days). These two parameters are also evaluated for exploratory purposes in the pre-operative, 3 months and 12 months follow-up visits. VAS neck pain is also evaluated for exploratory purposes at post-operative vi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Physical Summary Score (PSC) of the Short Form 36 (SF-36) questionnaire: a well-recognised measure of patient physical health 2. Mental Summary Score (MSC) of the Short Form 36 (SF-36) questionnaire: a well-recognised measure of patient mental health;Timepoint(s) of evaluation of this end point: SF36 is evaluated at screening, pre-operative and then 3, 6 and 12 months post-operatively | — |
Countries
United Kingdom
Contacts
Public ContactCarrie Bayliss
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Outcome results
None listed