SISTERS Clinical Trial

Title: “SISTERS: Spasticity in Stroke- Randomized Study”

Study Sponsor: Medtronic

Principal Investigator: Matthew Lawson, MD

Study Synopsis: A randomized, controlled, open-label, parallel-group, multi-center study to evaluate the efficacy and safety of Intrathecal Baclofen Therapy (ITB Therapy) compared to Best Medical Treatment (BMT) on severe spasticity in post-stroke patients after 6 months active treatment.

The primary objective is to demonstrate that ITB therapy, compared to BMT, has superior efficacy in the treatment of severe spasticity, in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities. Patients will be randomized to one of the two treatment arms, ITB therapy or the BMT arm. This study will randomize 88 patients with post-stroke severe spasticity. Patients will be recruited from approximately 20 sites in Europe and the United States.

Study Status: Open for enrollment.

For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.

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