Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain (NCT05598736) | Clinical Trial Compass
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Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain
Norway60 participantsStarted 2022-11-04
Plain-language summary
This study is based on 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) (NCT05562453). 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 (NCT05562453), all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part. The participants who volunteer to continue in the 6-months optional extension part will be included in this study.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Diagnosed MS according to revised McDonald criteria.
✓. Give written informed consent.
✓. Age 18-70 years.
✓. Stable MS disease without attack within the last three months.
✓. Ability to perform the walk tests:
✓. 2-minute walk test, and
✓. 25-Foot walk.
✓. Self-reported spasticity in the most affected leg that would be subject to treatment at baseline with a score of ≥ 4, scored using the numeric rating scale (NRS) during the last 24 hours.
Exclusion criteria
✕. Have spasticity due to a disease other than MS.
✕. Pregnancy or planned pregnancy within the upcoming study period, up to 7 months (includes the optional extension part).
What they're measuring
1
Change in self-reported spasticity using Numeric Rating Scale (NRS)
. Have an ongoing infection that subjectively affects their MS state, as judged by the Investigator.
✕. Have received botulinum toxin injection for spasticity within the last 4 months.
✕. Have symptoms or illness that make it difficult to participate in the study, as judged by the Investigator.
✕. Having planned surgery or other treatment within the coming study period of up to 7 months that makes it difficult to participate in the study, as judged by the Investigator.
✕. Subjects with uncontrolled wound infections or infections in the skin of the treated leg.