Dysport vs Botox for Upper Limb Spasticity

(DIRECTION Trial)

No longer recruiting at 95 trial locations

Overseen By Ipsen Recruitment Enquiries

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ipsen

Must be taking: Botulinum toxin

Must not be taking: Aminoglycosides, Curare-like agents

Disqualifiers: Neurological impairment, Neuromuscular disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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

I have never used BoNT-A for upper limb spasticity, or I have used it before.

I need Botox injections in certain muscles.

You have muscle weakness in at least two muscle groups, with one of them being the PTMG.

Exclusion Criteria

I haven't had surgery or specific treatments on my limb in the last 6 months.

I have not responded to Botox treatments in the past.

I don't have any health issues that could make this trial unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle 1

Participants receive one cycle of either aboBoNT-A or onaBoNT-A in the selected overactive upper limb muscles

24 weeks

Visits at baseline, 1 week, 4 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

Treatment Cycle 2

Participants receive a second cycle of the alternate treatment (aboBoNT-A or onaBoNT-A) in the selected overactive upper limb muscles

24 weeks

Visits at baseline, 1 week, 4 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Sequence 2 Experimental Treatment 2 Interventions

Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles

Group II: Sequence 1 Experimental Treatment 2 Interventions

Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

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

1. dysport.com dysport.com/en-us/hcp/adult-spasticity/efficacy

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7058702/

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01313299

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S193414821631187X

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 ...

5. ahajournals.org ahajournals.org/doi/10.1161/01.STR.31.10.2402

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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28625615/

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).

7. dysport.com dysport.com/en-us/hcp/adult-spasticity/safety

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 ...

8. neurology.org neurology.org/doi/10.1212/WNL.84.14_supplement.S28.001

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).

9. sciencedirect.com sciencedirect.com/science/article/pii/S0887899421001089

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 ...