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

NCT05562453 | Unknown

• 1 other identifier: CIV-22-04-039306
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Spasticity, Muscle; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Change in self-reported spasticity using Numeric Rating Scale (NRS)

  Numerical Rating Scale The minimum and maximum values: 0, 10 Higher scores mean a worse outcome the last 24 hours. The scale scores spasticity from 0-10, where 0 is no spasticity, and 10 is worst imaginable spasticity. The scoring should be done at roughly the same time of day and not during or immediately after treatment.

  4 weeks

Secondary Outcomes (7)

• Change in self-reported pain using NRS for subjects with a baseline NRS ≥4.

  4 weeks

• Frequency of adverse events

  4 weeks

• Change in timed 25-foot walk (T25-FW)

  4 weeks

• Change in 2-minute walking tests

  4 weeks

• Change in health-related quality of life measured by Multiple sclerosis impact scale (MSIS-29)

  4 weeks

Other Outcomes (7)

• The proportion of subjects with ≥ 30% improvement in self-reported pain using NRS

  4 weeks

• Mean daily treatment time

  4 weeks

• Proportion of subjects who wish to continue treatment with FlowOx2.0 beyond 4 weeks

  4 weeks

Study Arms (2)

Investigational device

EXPERIMENTAL

The investigational device (FlowOx2.0) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the commercial Pressure Chamber (and disposable parts). Subjects randomized to the investigational device arm will receive a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg.

Device: FlowOx 2.0

Comparator

SHAM COMPARATOR

The investigational device (FlowOx2.0) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the commercial Pressure Chamber (and disposable parts). Subjects randomized to the comparator arm will receive a Control Unit that generates INP pulses of only - (minus) 10 mmHg.

Device: FlowOx2.0 (Sham)

Interventions

FlowOx 2.0 DEVICE

Subjects randomized to tretament with the investigational device will receive treatment with -40 mmHg intermittent negative pressure for 60 minutes per day.

Also known as: Intermittent negative pressure (Active)

Investigational device

FlowOx2.0 (Sham) DEVICE

Subjects randomized to treatment with the comparator will receive treatment with -10 mmHg intermittent negative pressure for 60 minutes per day.

Also known as: Intermittent negative pressure (Sham)

Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• minute walk test, and
• 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.
• Stable and unchanged treatment of spasticity and pain over 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.

You may not qualify if:

• Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:
• 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).
• 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 making 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.

Sponsors & Collaborators

• Otivio AS: lead

Study Sites (1)

NeuroCentrum (Centrum för Neurologi)

Stockholm, 113 65, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity; Chronic Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Kjell-Morten Myhr, MD, PhD

  Dept. of Neurology Haukeland Univ. Hospital & Dept. of Clin. Med., Univ. of Bergen, Bergen, Norway

  PRINCIPAL INVESTIGATOR

• Sara Haghighi Mobarhan Smith, MD, PhD

  Department of Neurology, Motala Hospital, Motala, Sweden

  PRINCIPAL INVESTIGATOR

• Peter Vestergaard Rasmussen, MD, PhD

  Department of Clinical Medicine - The Department of Neurology, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, parallel design

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 30, 2022
• Study Start: October 4, 2022
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)