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Regeneration in Cervical Degenerative Myelopathy (RECEDE)

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ClinicalTrials.gov Identifier: NCT04631471
Recruitment Status : Not yet recruiting
First Posted : November 17, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Mark R Kotter, Cambridge University Hospitals NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Myelopathy Spinal Cord Diseases Drug: Ibudilast Procedure: Cervical decompressive surgery Drug: Matching placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : September 1, 2026
Estimated Study Completion Date : September 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Ibudilast
Increasing 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.

Procedure: Cervical decompressive surgery
Surgical decompression of degenerate cervical myelopathy

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
Procedure: Cervical decompressive surgery
Surgical decompression of degenerate cervical myelopathy

Drug: Matching placebo
Increasing 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.




Primary Outcome Measures :
  1. Change in modified Japanese Orthopaedic Association (mJOA) scale [ Time Frame: From baseline to 6 months follow-up ]
    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.

  2. Change in Visual Analogue Scale (VAS) neck pain [ Time Frame: From baseline to 6 months follow-up ]
    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).


Secondary Outcome Measures :
  1. PCS-SF36 [ Time Frame: From baseline to 6 months follow-up ]
    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.

  2. MCS-SF36 [ Time Frame: From baseline to 6 months follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
  • 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 study 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 study procedures, IMP regime or follow-up schedule
  • Unable to take a gelatin based product
  • Participation in another CTIMP or device within the past 30 days from the time of recruitment
  • Functional disability from a commitment 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 study drug
  • Unable to converse, read or write English at primary school level

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631471


Contacts
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Contact: Mark R Kotter, PhD +44 1223 747476 mrk25@cam.ac.uk
Contact: Daniel Alvarez-Berdugo, PhD 01223254684 daniel.alvarezberdugo@addenbrookes.nhs.uk

Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Benjamin Davies, MD Cambridge University Hospital, Department of Neurosurgery
Publications:

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Responsible Party: Mark R Kotter, Principal Investigator, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04631471    
Other Study ID Numbers: CCTU0178
2017-004856-41 ( EudraCT Number )
213009 ( Registry Identifier: IRAS )
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant's data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark R Kotter, Cambridge University Hospitals NHS Foundation Trust:
Degenerative
Cervical
Myelopathy
Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases
Ibudilast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents