nctId: NCT06340451 id: IOV-301 briefTitle: Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-04 date: 2024-04-01 date: 2024-04-23 name: Pacira Pharmaceuticals, Inc class: INDUSTRY 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). conditions: Spasticity, Cerebral or Spinal Condition studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 132 type: ESTIMATED name: iovera° system name: sham iovera° system treatment 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) measure: Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured 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) measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) 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) measure: Change from baseline in the Modified Ashworth Scale score for elbow measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score for shoulder (shoulder abduction) measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score for shoulder (forward flexion, external rotation) measured immediately (within 3 hours) 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) 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) measure: Change from baseline in the Modified Tardieu Scales for elbow measured immediately (within 3 hours) measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) measured immediately (within 3 hours) measure: Change from baseline in the Modified Tardieu Scales for shoulder (forward flexion, external rotation) measured immediately (within 3 hours) measure: Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shepherd Center status: RECRUITING city: Atlanta state: Georgia zip: 30309 country: United States name: Michelle Tidwell role: CONTACT phone: 404-367-1317 email: michelle.tidwell@shepherd.org lat: 33.749 lon: -84.38798 hasResults: False