Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity

Summary

This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A., approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a 21-day screening period, a treatment visit and follow-up visits. The protocol was amended and the study was completed with fewer subjects than described in the initial protocol due to impact of COVID-19 on enrollment.

Timeline

Start

2018-12-12

Primary completion

2020-11-23

Completion

2020-11-23

Outcome

Mixed primary results

registry LEAST_SQUARES_MEAN DAXI 500 U: -1.5 (Standard Error 0.27) score on a scale NCT03821402 ↗

registry LEAST_SQUARES_MEAN Placebo: -0.8 (Standard Error 0.26) score on a scale NCT03821402 ↗

registry analysis (superiority test); DAXI 500 U vs Placebo; p = 0.0488; ANCOVA NCT03821402 ↗

registry analysis (superiority test); DAXI 250 U vs Placebo; p = 0.7645; ANCOVA NCT03821402 ↗

registry analysis (superiority test); DAXI 375 U vs Placebo; p = 0.5509; ANCOVA NCT03821402 ↗

registry analysis (superiority test); DAXI 250 U vs Placebo; p = 0.3698; ANCOVA NCT03821402 ↗

registry analysis (superiority test); DAXI 375 U vs Placebo; p = 0.1972; ANCOVA NCT03821402 ↗

registry analysis (superiority test); DAXI 500 U vs Placebo; p = 0.2037; ANCOVA NCT03821402 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	250 iu	—
Subject	Botulinum toxin type A	Protein / enzyme biologic	375 iu	—
Subject	Botulinum toxin type A	Protein / enzyme biologic	500 iu	—

Indications

No indication recorded.