Session Information
Session Title: AA 2022 Posters - Neurological Rehabilitation
Session Time: None. Available on demand.
Disclosures: Atul T. Patel, MD, MHSA: Abbvie (Products/Services: No) (Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)IPSEN (Products/Services: No) (Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Revance (Products/Services: Yes) (Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received)
Background and/or Objectives: Evaluate the efficacy and safety of 3 doses of DaxibotulinumtoxinA for Injection (DAXI) vs placebo for treatment of adult upper limb spasticity (AULS) after stroke or traumatic brain injury.
Design: Randomized, double-blind, placebo-controlled study.
Setting: 27 centers in the United States.
Participants: 83 male (59%) and female adults with AULS after stroke (95.2%) or traumatic brain injury (4.8%).
Interventions: Subjects were randomized to receive a total dose of DAXI 500U (n=18), 375U (n=19), 250U (n=22), or placebo (n=24) into targeted muscles and followed for 36 weeks.
Main Outcome Measures: Co-primary endpoints were Modified Ashworth Scale (MAS) change from baseline in a pre-defined suprahypertonic muscle group (SMG) and Physician Global Impression of Change (PGIC) at Week 6.
Results: A statistically significant and clinically meaningful improvement from baseline in MAS for the SMG was observed with DAXI 500U at Week 4 (DAXI 500U -1.8 [-46.1%] vs placebo 0.6 [-15.0%]; p=0.0002) and Week 6 (DAXI 500U -1.5 [-38.5%] vs placebo -0.8 [ 20.0%]; p=0.0488). Improvements in MAS for DAXI 250U and 375U at Week 4 (-0.9 [ 22.5%] and -0.9 [-22.5%], respectively) and Week 6 (-0.9 [-22.5%] and -1.0 [-25.0%]) did not differ significantly from placebo. Mean PGIC at Week 4 for DAXI 375U (1.7) and 500U (1.8) was significantly improved vs placebo (0.9; p=0.0150 and p=0.0092, respectively). Median duration of effect, defined as time to loss of improvement in SMG (MAS return to baseline) and PGIC ≤0, or subject requesting re-treatment, was 24.7 weeks in the DAXI 500U group. DAXI 250U, 375U, and 500U were well tolerated, with no trend toward more adverse events with increasing dose.
Conclusions: Results from this Phase 2 study, completed with reduced enrollment due to COVID-19, indicate DAXI at doses of 500U is effective and well tolerated for treating AULS. These data provide sufficient information to advance to a Phase 3 study.
Level of Evidence: Level II
To cite this abstract in AMA style:
Patel AT, Kesslak JP, Gross TM, Rubio RG, Francisco GE, Munin MC, Ayyoub Z. A Randomized, Double-blind, Placebo-controlled Study of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury (JUNIPER) [abstract]. PM R. 2022; 14(S1)(suppl 1). https://pmrjabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-study-of-daxibotulinumtoxina-for-injection-for-the-treatment-of-upper-limb-spasticity-in-adults-after-stroke-or-traumatic-brain-injury-juniper/. Accessed May 11, 2025.« Back to AAPM&R Annual Assembly 2022
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-study-of-daxibotulinumtoxina-for-injection-for-the-treatment-of-upper-limb-spasticity-in-adults-after-stroke-or-traumatic-brain-injury-juniper/