NCT05598736Befejeződött
Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain
An Open 6-month Investigation, to Evaluate the Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis (Optional Continuation From NCT05562453)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 19.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 58 (tényleges)
- Első benyújtás
- 2022. okt. 25.
- Kezdés
- 2022. nov. 4.
- Elsődleges befejezés
- 2024. jan. 2.
- Fő szponzor
- Otivio AS
- Betegségek
- Sclerosis multiplex (SM)
- NCT-szám
- NCT05598736
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 58
- 2022. nov. 4. és az elsődleges befejezés (2024. jan. 2.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Have received botulinum toxin injection for spasticity within the last 4 months.
- 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.
Más betegség
- Have spasticity due to a disease other than MS.
- Have an ongoing infection that subjectively affects their MS state, as judged by the Investigator.
- Have symptoms or illness that make 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.
Egyéb
- Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:
- Pregnancy or planned pregnancy within the upcoming study period, up to 7 months (includes the optional extension part).
Kiket keres a vizsgálat
- The subjects must meet all the following criteria to be eligible to participate in the clinical investigation:
- 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.
- Pain and/or discomfort related to the spasticity described in inclusion criteria 6., over the last 7 days using the numeric rating scale (NRS).
- Stable and unchanged treatment of spasticity and pain the last month, as judged by the Investigator.
- Stable and unchanged disease-modulating treatment for MS last 6 months, as judged by the Investigator.
- Can self-manage study equipment.
- Willingness and ability to comply with study procedures, visit schedules, and requirements.
- Conducted the 4-week double-blind part of the study (NCT05562453).
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Dept. of Neurology Haukeland Univ. Hospital & Dept. of Clin. Med., Univ. of Bergen, Bergen, Norway | Bergen | Norvégia | Ismeretlen állapot |
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