Dysport vs Botox for Upper Limb Spasticity

(DIRECTION Trial)

Recruiting at 92 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

464 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two types of botulinum toxin injections to see which one is safer and lasts longer in relaxing muscles. Botulinum toxin has been used in various medical treatments, including for muscle spasticity, overactive bladder syndrome, and cerebral palsy.

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 data supports the effectiveness of the drug for treating upper limb spasticity?

Research shows that abobotulinumtoxinA (Dysport) is effective in reducing muscle spasticity in the upper limbs, with significant improvements in muscle tone and limb function observed in clinical practice. In a study, 96.4% to 98.6% of patients showed improvement after treatment, as assessed by both patients and doctors. ^{1 2 3 4 5}

Is Dysport (abobotulinumtoxinA) safe for treating upper limb spasticity?

Dysport (abobotulinumtoxinA) has a well-established safety profile in treating muscle spasticity, including upper limb spasticity, and no new adverse events were reported in recent studies. ^{1 4 6 7 8}

How does the drug Dysport differ from other treatments for upper limb spasticity?

Dysport (abobotulinumtoxinA) is unique because it is a formulation of botulinum toxin A that blocks acetylcholine release at neuromuscular junctions, leading to temporary muscle paralysis. It is administered through injections and has been shown to improve muscle tone and limb function in patients with upper limb spasticity, with effects lasting several months. ^{1 3 4 9 10}

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. Poland pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of abobotulinumtoxinA (Dysport®) in adults with upper limb spasticity in routine clinical practice: an observational study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of abobotulinumtoxinA (Dysport) and onabotulinumtoxinA (Botox) for managing spasticity of the upper and lower limbs, and cervical dystonia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of repeated abobotulinumtoxinA injections in upper limb spasticity. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA Efficacy/Safety in Upper-Limb Spasticity in Pediatric Cerebral Palsy: Randomized Controlled Trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of botulinum neurotoxin type A injections in naïve and previously-treated patients suffering from Torti- or Laterocollis or -caput: Results from a German-Austrian open-label prospective post-marketing surveillance study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Botulinum toxin A (Dysport®): in dystonias and focal spasticity. [2022]