Dysport vs Botox for Upper Limb Spasticity
(DIRECTION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two botulinum toxin treatments, Dysport (aboBoNT-A) and Botox (onaBoNT-A), to determine if Dysport is as safe and possibly more effective for treating upper limb spasticity (muscle stiffness). Participants will receive both treatments in different sequences to compare their effects. It suits individuals with stable upper limb spasticity for at least three months who require treatment in only one arm. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, if you are on oral antispasticity, anticoagulant, or anticholinergic medications, you need to have been stable on them for at least 3 months before joining the study and are expected to remain stable during the study.
What is the safety track record for AboBoNT-A and OnaBoNT-A?
A previous study found that abobotulinumtoxinA (aboBoNT-A) had a low rate of side effects. Fewer than 2% of patients reported issues such as difficulty swallowing, trouble walking, or muscle stiffness, which are considered rare. In contrast, onabotulinumtoxinA (onaBoNT-A) has been shown to reduce muscle tension and improve movement in individuals with muscle stiffness. It is well-tolerated, with most people not experiencing serious side effects. Both treatments have been widely used and are generally safe, posing minimal risk of harm or discomfort.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about using Dysport (AboBoNT-A) and Botox (OnaBoNT-A) for upper limb spasticity because these treatments offer targeted muscle relaxation with potentially different onset and duration of effects. Both are forms of botulinum toxin type A, but they have unique formulations that might affect how quickly they start working and how long their benefits last. This study aims to compare these two treatments directly to identify any differences in efficacy and patient outcomes, which could lead to more personalized treatment strategies for those with spasticity.
What evidence suggests that this trial's treatments could be effective for upper limb spasticity?
Research has shown that Dysport (abobotulinumtoxinA) reduces muscle tightness and pain related to muscle stiffness in adults with upper limb spasticity. One study found that 75.7% and 87.5% of patients receiving Dysport experienced improvements, compared to 41.7% of those receiving a placebo. Similarly, Botox (onabotulinumtoxinA) significantly reduces involuntary movements and pain from muscle stiffness and has improved muscle tone in adults with spasticity. In this trial, participants will receive either Dysport followed by Botox or Botox followed by Dysport. Both treatments have effectively improved patients' quality of life by reducing symptoms and enhancing function.36789
Who Is on the Research Team?
Ipsen Medical Director
Principal Investigator
Ipsen
Are You a Good Fit for This Trial?
Adults aged 18-80 with stable upper limb spasticity for at least 3 months, needing treatment in only one arm. Suitable for those new to or previously treated with BoNT-A injections, and not on conflicting medications or treatments. Excludes pregnant women, those with certain medical conditions like dysphagia or neuromuscular disorders, recent BoNT users, and individuals allergic to any BoNT product ingredients.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Cycle 1
Participants receive one cycle of either aboBoNT-A or onaBoNT-A in the selected overactive upper limb muscles
Treatment Cycle 2
Participants receive a second cycle of the alternate treatment (aboBoNT-A or onaBoNT-A) in the selected overactive upper limb muscles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AboBoNT-A
- OnaBoNT-A
Trial Overview
The trial is testing the safety of Dysport (aboBoNT-A) against Botox (onaBoNT-A), focusing on adverse effects as a primary point. It also compares how long each drug's effect lasts when used at recommended doses for muscle spasms in one upper limb.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles
Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ipsen
Lead Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD
Citations
Study design for adult upper limb spasticity
The efficacy and safety of Dysport were evaluated in a randomized, multicenter, double-blind, placebo-controlled study in 238 adults with upper limb spasticity ...
Effectiveness of AbobotulinumtoxinA in Post-stroke Upper ...
Treatment with abobotulinumtoxinA was consistently effective in reducing spasticity as well as spasticity/stretch- related pain, whether started early after the ...
NCT01313299 | Dysport® Adult Upper Limb Spasticity
The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb ...
Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the ...
PGA scores ≥1 were achieved by 75.7% and 87.5% of abobotulinumtoxinA 500 and 1000 U subjects versus 41.7% with placebo. Perceived function (Disability ...
A Randomized, Double-Blind, Placebo-Controlled, Dose ...
Conclusions—The present study suggests that treatment with Dysport reduces muscle tone in patients with poststroke upper limb spasticity. Treatment was ...
Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the ...
Objective: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A).
Safety results in adult upper limb spasticity
Adverse reactions with an incidence of less than 2% reported in Dysport treatment groups included dysphagia 0.5%, gait disturbance 0.5%, hypertonia 0.5%, and ...
A Phase III randomized, double-blind, placebo-controlled ...
OBJECTIVE: To assess the efficacy and safety of abobotulinumtoxinA (Dysport®) in the treatment of hemiparetic adults with upper limb spasticity (ULS).
IncobotulinumtoxinA Efficacy/Safety in Upper-Limb ...
IncobotulinumtoxinA was generally well tolerated at all doses and across all treatment cycles, in patients representing the range of GMFCS levels. During the MP ...
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