Clinical Trial

Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

Active, Not Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 5 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-07
notable Primary completion pushed: 2026-08 -> 2026-10 2026-07-07
minor Completion pushed: 2026-08 -> 2026-10 2026-07-07
notable Primary completion pushed: 2026-03 -> 2026-08 2026-04-10
minor Completion pushed: 2026-03 -> 2026-08 2026-04-10
Trial Details
NCT Number NCT06340451
Lead Sponsor Pacira Pharmaceuticals, Inc
Conditions Spasticity, Cerebral or Spinal Condition
Enrollment 132 participants
Start Date 2024-07-11
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-06