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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04631471
Other study ID # CCTU0178
Secondary ID 2017-004856-4121
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 22, 2021
Est. completion date September 1, 2026

Study information

Verified date December 2021
Source Cambridge University Hospitals NHS Foundation Trust
Contact Mark R Kotter, PhD
Phone +44 1223 747476
Email mrk25@cam.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United Kingdom Addenbrooke's Hospital Cambridge

Sponsors (1)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (80)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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. From baseline to 6 months follow-up
Primary 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). From baseline to 6 months follow-up
Secondary 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. From baseline to 6 months follow-up
Secondary 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. From baseline to 6 months follow-up
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