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Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain — FO-NP002  

Multiple Sclerosis Clinical Trial

Official title:
A Double-blind, Randomized, Controlled, Parallel Design 4-week Investigation, Followed by an Open 6-month Investigation, to Evaluate the Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis

Clinical Trial Summary

The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.

Clinical Trial Description

FlowOx2.0™ is a commercially available device for home treatment of peripheral arterial disease. It is designed to be used at home by patients and has been shown to cause rapid changes in blood flow velocity in the treated leg. Recently, individuals with multiple sclerosis have reported a positive impact on their self-perceived spasticity and pain levels. The purpose of this study is to control for potential placebo effects using a comparator device. The study will recruit patients from Norway, Sweden, and Denmark. All subjects will be instructed to treat the most affected leg for 60 minutes per day, preferentially in the evening. The same leg should be treated throughout the study period. The 4-week double-blind part is immediately followed by an optional extension part. This part is an open investigation in which all randomized subjects that have completed the main part are offered to continue for an additional 6 months using the active device (INP pulses of - 40 mmHg). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05562453
Study type Interventional
Source Otivio AS
Contact
Status Active, not recruiting
Phase N/A
Start date October 4, 2022
Completion date August 15, 2023
View Details
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