Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spast… (NCT06340451) | Clinical Trial Compass
RecruitingNot Applicable
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
United States132 participantsStarted 2024-07-11
Plain-language summary
This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, 18 years and above.
✓. A confirmed diagnosis of any cerebral or spinal condition, at least 6 months before Screening, resulting in spasticity of the muscles controlling the shoulder and elbow.
✓. Not on oral medications for spasticity management or if on any oral medications, the oral medication taken chronically for spasticity management (eg, oral baclofen) must be maintained at a stable dose for at least 4 weeks before screening for the study.
✓. Not on an intrathecal baclofen pump or if on an intrathecal baclofen pump for spasticity management, must be maintained at a stable dose for six months or more before screening for the study.
✓. Must have a score on the Modified Ashworth Scale of 2 or more in the targeted area (shoulder and elbow) at Screening and at Baseline (Day-1 pretreatment).
✓. A diagnostic nerve block using lidocaine (1% lidocaine, 2 to 3 mL per target nerve) showing a positive response (at least one point reduction from the screening Modified Ashworth Scale score for elbow extension and shoulder abduction) to the targeted nerves, should be performed within 30 days to at least 6 hours before study treatment. The diagnostic nerve block effect must be completely resolved before pretreatment evaluation and the study treatment.
✓. Subject, in the investigator's opinion, will not be exposed to unacceptable risk by participation.
✓. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Exclusion criteria
✕
What they're measuring
1
Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity)