Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain (NCT05598736) | Clinical Trial Compass
UnknownNot Applicable
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in self-reported spasticity using Numeric Rating Scale (NRS)
. Pregnancy or planned pregnancy within the upcoming study period, up to 7 months (includes the optional extension part).
. 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.