BridgeMD
New treatment option for Myelopathy
Official title Regeneration in Cervical Degenerative Myelopathy
ClinicalTrials.gov ID: NCT04631471
What this study is testing
What is Ibudilast?
Ibudilast is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for myelopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 15 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and...
- Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study...
See the full eligibility 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
- 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 \>...
- 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...
- Resting pulse \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 15 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.