Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-11-27
Brief Title:
Remote Ischemic Conditioning in PPMS
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Open-label Single-center Single-arm Futility Trial Evaluating Daily Remote Ischemic Conditioning for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis PPMS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Progressive MS remains the most difficult therapeutic challenge Remyelination is a promising therapeutic strategy but an effective pharmacologic intervention remains elusive Remote ischemic conditioning RIC is a non-pharmacologic intervention that has been studied in the context of stroke where transient limb ischemia leads to neuroprotection However RIC has not yet been studied in MS The investigators hypothesized that repeating RIC over several days may induce molecularcellular changes in the CNS that promote remyelination Since RIC is safe tolerable and ready for clinical translation recent stroke trials have shown promise the investigators will run a clinical study to test RIC in people with primary progressive MS
The purpose of this clinical trial is to determine if RIC in a dose of 4 cycles daily can prevent worsening of walking ability in people PPMS The trial is funded through MS Canada as well as a private donation to the Hotchkiss Brain Institute MS Translational Clinical Trials Research Program and the University of Calgary There is no sponsorship from the pharmaceutical industry
The purpose of this clinical trial is to determine if RIC in a dose of 4 cycles daily can prevent worsening of walking ability in people PPMS The trial is funded through MS Canada as well as a private donation to the Hotchkiss Brain Institute MS Translational Clinical Trials Research Program and the University of Calgary There is no sponsorship from the pharmaceutical industry
Detailed Description:
Remote Ischemic conditioning RIC Ischemic-preconditioning entails inducing short periods of cyclical tissue ischemia that confers subsequent protection against ischemia-reperfusion-injury The rationale is that short periods of ischemia do not cause irreversible injury but instead induce an endogenous protective environment This short period of ischemia is not injurious and it triggers endogenous protective signals such as anti-inflammatory and antioxidant molecules that reach distant organs such as the heart liver or the CNS As an endogenous non-specific response the mechanisms involved in RIC are complex and include inflammation oxidative stress changes in endothelial function cell survival etc
Current treatments for progressive Multiple Sclerosis the immune-modulators Siponimod and Ocrelizumab are only modestly effective and primarily benefit people with active inflammatory disease activity recent relapses andor enhancing lesions on MRI Progression free of inflammatory activity is characterized by slow accumulation of disability greatly affecting quality of life in people with Multiple Sclerosis MS The investigators believe RIC is ideally suited to be tested as a therapy for progression in MS Recent clinical trials in vascular disease have shown that daily RIC can be performed for up to a year and suggested an all-cause mortality benefit In a recent RICAMIS trial 2022 multicenter randomized trial of people with acute ischemic stroke 1000 participants 14-day RIC treatment led to improved functional outcomes at 6-months No serious side effects were reported and tolerability was good
This important study was the first phase III trial to find a protective effect for RIC in neurological disease and highlights the timeliness and potential for re-purposing RIC as a therapy for MS
In this trial the investigators will investigate whether RIC treatment can prevent disability worsening in people with Primary Progressive MS PPMS
The primary objective of this trial is to demonstrate non-futility of RIC for reducing progression of disability as measured with the timed 25-foot walk T25FW in people with PPMS
This is a phase II open-label single-center single-arm futility trial The study will follow the Simon-2-stage MiniMax design for futility studies
Current treatments for progressive Multiple Sclerosis the immune-modulators Siponimod and Ocrelizumab are only modestly effective and primarily benefit people with active inflammatory disease activity recent relapses andor enhancing lesions on MRI Progression free of inflammatory activity is characterized by slow accumulation of disability greatly affecting quality of life in people with Multiple Sclerosis MS The investigators believe RIC is ideally suited to be tested as a therapy for progression in MS Recent clinical trials in vascular disease have shown that daily RIC can be performed for up to a year and suggested an all-cause mortality benefit In a recent RICAMIS trial 2022 multicenter randomized trial of people with acute ischemic stroke 1000 participants 14-day RIC treatment led to improved functional outcomes at 6-months No serious side effects were reported and tolerability was good
This important study was the first phase III trial to find a protective effect for RIC in neurological disease and highlights the timeliness and potential for re-purposing RIC as a therapy for MS
In this trial the investigators will investigate whether RIC treatment can prevent disability worsening in people with Primary Progressive MS PPMS
The primary objective of this trial is to demonstrate non-futility of RIC for reducing progression of disability as measured with the timed 25-foot walk T25FW in people with PPMS
This is a phase II open-label single-center single-arm futility trial The study will follow the Simon-2-stage MiniMax design for futility studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None