Randomised Placebo-controlled Double Blind Clinical Trial in Degenerative Cervical Myelopathy: The RECEDE Myelopathy Trial

Phase 1

• Conditions: Degenerative Cervical Myelopathy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004856-41-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-23
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 362

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

• 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 <5000
• Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
• Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or trial participation
• Female patients with child bearing potential who are unwilling or unable to use reliable methods of contraception
• Female patients who are pregnant, lactating or planning pregnancy during the course of the trial.
• Inability to comply with trial procedures or follow-up schedule including IMP regime
• Unable to take gelatin based product
• Participation in another CTIMP or device within the past 30 days from the time of recruitment
• Functional disability from a concomitant neurological disease that would mask the symptoms of DCM (at the discretion of the investigator). Including but not limited to stroke with residual disability, cerebellar ataxia, Parkinson’s disease, symptomatic lumbar stenosis and multiple sclerosis.
• Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or QTcF > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified