A Randomized, Double-Blind, Active Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Liztox ® versus Botox ® in Post-Stroke Upper Limb Spasticity

• Published in: Toxins Vol. 15; no. 12; p. 697
• Main Authors: Ye, Dong Hyun, Chun, Min Ho, Park, Yoon Ghil, Paik, Nam-Jong, Lee, Shi-Uk, Yoo, Seung Don, Kim, Deog Young
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 01.12.2023; MDPI
• Subjects: Active control; Botulinum toxin; Botulinum toxin type A; Care and treatment; Caregivers; Clinical significance; Clinical trials; Dosage and administration; Effectiveness; Elbow; Flexors; Hygiene; Immunoglobulin A; Injection; Limbs; Oral administration; Patient outcomes; Patients; Quality of life; Response rates; Safety; Spasticity; Statistical analysis; Stroke; Testing; Toxins; upper extremity; Wrist; South Korea; botulinum toxin; spasticity; stroke; upper extremity
• ISSN: 2072-6651; 2072-6651
• DOI: 10.3390/toxins15120697

Botulinum toxin type A (BTX-A) injection is a commonly used therapeutic intervention for upper limb spasticity in stroke patients. This study was designed as a randomized, active-drug-controlled, double-blind, multicenter, phase 3 clinical trial to evaluate the safety and efficacy of Liztox in comparison to onabotulinum toxin A (Botox ) for individuals with post-stroke upper limb spasticity. The primary outcome was the alteration in wrist flexor muscle tone from the initial assessment to the fourth week, evaluated using the modified Ashworth scale (MAS). Secondary outcomes included MAS score changes for the wrist at weeks 8 and 12 from baseline; MAS score changes for finger and elbow flexors; and changes in the Disability Assessment Scale (DAS), Subject's Global Assessment (SGA), the Investigator's Global Assessment (IGA), and Caregiver Burden Scale (CBS) at weeks 4, 8, and 12 from baseline. The MAS score for wrist flexor spasticity decreased by -1.14 ± 0.59 in the Liztox group and -1.22 ± 0.59 in the Botox group from baseline to week 4. The difference [97.5% confidence interval (CI)] between the test and control groups was 0.08 [-∞, 0.26], confirming the non-inferiority of the test group compared to the control group. Furthermore, there were consistent improvements in the IGA, SGA, and CBS scores across all assessment intervals, with no statistically significant variances detected between the two groups. No safety-related concerns were reported during the study. In conclusion, Liztox injection proved to be a secure and efficacious intervention for managing upper extremity spasticity in post-stroke patients.