protocolSection identificationModule nctId: NCT06340451, orgStudyIdInfo id: IOV-301, briefTitle: Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Pacira Pharmaceuticals, Inc, class: INDUSTRY, descriptionModule briefSummary: 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)., conditionsModule conditions: Spasticity, Cerebral or Spinal Condition, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: iovera° system, interventions name: sham iovera° system treatment, outcomesModule primaryOutcomes measure: 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), secondaryOutcomes measure: Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured, secondaryOutcomes measure: Change from baseline in the Modified Tardieu Scales for elbow (0 to 5, where lower score represents no resistance, and higher score represents joint immobility; Increase in angle from baseline [R1, and R2] represents improvement), secondaryOutcomes measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction), secondaryOutcomes measure: Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff (-2 to +2, where lower score represents less expected outcomes, and higher scores represent greater expected outcomes), otherOutcomes measure: Change from baseline in the Modified Ashworth Scale score for elbow measured immediately (within 3 hours), otherOutcomes measure: Change from baseline in the Modified Ashworth Scale score for shoulder (shoulder abduction) measured immediately (within 3 hours), otherOutcomes measure: Change from baseline in the Modified Ashworth Scale score for shoulder (forward flexion, external rotation) measured immediately (within 3 hours), otherOutcomes measure: Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by area under the curve (AUC) for elbow (elbow extension), otherOutcomes measure: Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by AUC for shoulder (shoulder abduction, shoulder forward flexion, external rotation), otherOutcomes measure: Change from baseline in the Modified Tardieu Scales for elbow measured immediately (within 3 hours), otherOutcomes measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) measured immediately (within 3 hours), otherOutcomes measure: Change from baseline in the Modified Tardieu Scales for shoulder (forward flexion, external rotation) measured immediately (within 3 hours), otherOutcomes measure: Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shepherd Center, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30309, country: United States, contacts name: Michelle Tidwell, role: CONTACT, phone: 404-367-1317, email: michelle.tidwell@shepherd.org, geoPoint lat: 33.749, lon: -84.38798, hasResults: False