Status:
NOT_YET_RECRUITING
Remote Ischemic Conditioning in PPMS
Lead Sponsor:
University of Calgary
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 conditio...
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 rati...
Eligibility Criteria
Inclusion
- Written informed consent obtained
- Men and women aged of 18 and 65 years inclusive
- With Primary Progressive Multiple Sclerosis, according to current diagnostic criteria
- Screening Expanded Disability Status Scale score between 4.0 and 6.5 inclusive
- Screening timed 25-foot walk (average of two trials) of 5.5 seconds or more
Exclusion
- Patients whose screening MRI scan shows gadolinium enhancing lesions
- Patients with known renal insufficiency
- Patients with known significant hepatic impairment
- Patients with known allergy to gadolinium MRI contrast agent
- Patients currently using immune-modulators such as ocrelizumab or hydroxychloroquine
- Patients currently using therapeutic anticoagulation (blood thinners, such as warfarin, apixaban, rivaroxaban, dabigatran, enoxaparin)
- Patients currently using Fampridine or 4-aminopyridine
- Patients planning to start Fampridine or 4-aminopyridine during the study period
- Patients planning to start Baclofen or Tizanidine during the duration of the study
- Patients who increase the dose of Baclofen or Tizanidine during the study period
- Patients who receive treatment with Botulinum toxin in the leg muscles during the study period
- Patients who are unable or unwilling to undergo gadolinium enhanced MRI scans
- Patients with known history of thrombotic events in the upper extremities
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06171334
Start Date
July 1 2024
End Date
December 1 2026
Last Update
May 9 2024
Active Locations (1)
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1
University of Calgary
Calgary, Canada