What is the mechanism of action of this treatment?

The most common treatments for Upper Limb Spasticity, such as AbobotulinumtoxinA (aboBoNT-A) and OnabotulinumtoxinA (onaBoNT-A), work by inhibiting the release of acetylcholine at the neuromuscular junction. This inhibition prevents muscle contractions, thereby reducing spasticity. This mechanism is particularly important for patients with Upper Limb Spasticity as it directly addresses the overactivity of muscles, leading to decreased stiffness and improved functional abilities. Understanding how these treatments work helps in making informed decisions about managing spasticity effectively.

What side effects are associated with this type of intervention?

The most common side effects of treatments for upper limb spasticity using botulinum toxin type A, such as AbobotulinumtoxinA (aboBoNT-A) and OnabotulinumtoxinA (onaBoNT-A), include localized pain at the injection site, muscle weakness, and flu-like symptoms. Other potential side effects are bruising, swelling, and temporary loss of function in the injected muscles. In rare cases, patients may experience more severe reactions such as difficulty swallowing or breathing, which require immediate medical attention.

What prior FDA approvals exist?

The FDA has approved several botulinum toxin products for the treatment of Upper Limb Spasticity, including AbobotulinumtoxinA (Dysport®) and OnabotulinumtoxinA (Botox®). These treatments work by inhibiting the release of acetylcholine at the neuromuscular junction, thereby reducing muscle spasticity. Both Dysport® and Botox® have been shown to be effective and safe for managing spasticity in various clinical trials.

What other types of research exist?

Promising novel alternatives to AbobotulinumtoxinA for Upper Limb Spasticity include botulinum toxin type B (BTX-B; Myobloc/Neurobloc), which has shown muscle weakening efficacy and safety in preclinical models. Other emerging treatments may include antisense oligonucleotide therapies and other neuromodulatory agents currently under investigation.

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Neurotoxin

Dysport vs Botox for Upper Limb Spasticity (DIRECTION Trial)

Phase 4

Recruiting

Research Sponsored by Ipsen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or who have been previously treated with BoNT-A for ULS

Participants who require BoNT-A injection in specific muscles

Must not have

Prior history of non-responsiveness to BoNT treatment

Infection at the proposed injection site(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks)

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include pain at the injection site, muscle weakness near where the medicine was injected, fatigue, headache, neck pain and difficulty swallowing. Some people might experience spread of toxin effects causing symptoms like breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I need Botox injections in certain muscles.

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I am between 18 and 80 years old.

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I have difficulty with dressing, hygiene, moving, or pain.

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I have never used or have previously used Botulinum toxin type A for upper limb spasticity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not responded to Botox treatments in the past.

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I have an infection where I might get an injection.

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I am not pregnant or breastfeeding.

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I have not received Botox treatment in the last 12 weeks and do not plan to during the study.

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I have significant movement restrictions in my affected arm.

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I have a condition affecting my nerves or muscles, like ALS or myasthenia gravis.

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I do not have major brain or nerve problems affecting my daily activities.

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I need injections in muscles not listed in the study or in both arms/legs during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Quality of Life (QoL) using SQoL-6D

Change in Quality of Life (QoL) using the SF-12 perceived health score

Muscle tone assessed by Modified Ashworth scale (MAS) total score

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sequence 2Experimental Treatment2 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 1Experimental Treatment2 Interventions

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Upper Limb Spasticity, such as AbobotulinumtoxinA (aboBoNT-A) and OnabotulinumtoxinA (onaBoNT-A), work by inhibiting the release of acetylcholine at the neuromuscular junction. This inhibition prevents muscle contractions, thereby reducing spasticity. This mechanism is particularly important for patients with Upper Limb Spasticity as it directly addresses the overactivity of muscles, leading to decreased stiffness and improved functional abilities. Understanding how these treatments work helps in making informed decisions about managing spasticity effectively.

Treatment in myotonia and periodic paralysis.Presynaptic protein interactions in vivo: evidence from botulinum A, C, D and E action at frog neuromuscular junction.